| GENERAL MATERIAL INFORMATION | |
| General Information | Valsartan and hydrochlorothiazide film coated tablets is consisting of Valsartan and hydrochlorothiazide and Excipients. |
| Categories | Antihypertensive |
| Composition | Each film coated tablet contains:
Valsartan( 80 mg) and hydrochlorothiazide (12.5mg) IP Valsartan (160 mg) and hydrochlorothiazide (12.5mg)IP |
| Reference | Indian Pharmacopoeia 2022 |
| Sample Quantity | Chemical Analysis = 60 Tablets
Microbiology Analysis = 20 Tablets |
| Shelf Life | 24 Months
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| Hazards and Precaution, If any | Use nose mask and hand gloves while sampling at bulk stage
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| Storage | Store protected from moisture at a temperature not exceeding 30°.
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| S.NO. | TESTS | SPECIFICATIONS | REFERENCE | ||
| 1. | Description | ||||
| 2. | Average weight | ||||
| 3. | Uniformity of weight | ||||
| 4. | Identification
|
A. Determine by thin-layer chromatography ,coating the plate with silica gel GF254.
Mobile phase. A mixture of 80 volumes of ethyl acetate,20 volumes of dehydrated alcohol and 10 volumes of a 25 percent w/v solution of ammonium hydroxide.
Test solution. Disperse a quantity of powdered tablets containing about 20 mg of valsartan in 100 ml of acetone, sonicate for 15 minutes and filter. Reference solution. A solution equivalent to test concentrations of valsartan IPRS and hydrochlorothiazide IPRS in acetone .Apply to the plate 2 µl of each solution. Allow the mobile phase to rise 7 cm. Dry the plate in a current of warm air and examine under ultraviolet light at 254 nm. The principal spot in the chromatogram obtained with the test solution corresponds to that in the chromatogram obtained with the reference solution. B. In the Assay, the retention time of the principal peak in the chromatogram obtained with the test solution corresponds to that in the chromatogram obtained with the reference solution.
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| 5. | Hardness | ||||
| 6. | Disintegration Time | NMT | |||
| 7. | Dimension |
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| 8. | Friability | NMT | |||
| 9. | Dissolution | NLT 80% | |||
| 10. | Leak Test | Should be Pass | |||
| 11. | Related Substance | Determine by liquid chromatography, as described under Assay using the following
solutions. Solvent mixture. Equal volumes of acetonitrile and water. Test solution. Disperse a quantity of powdered tablets containing about 62.5 mg of Hydrochlorothiazide with 5.0 ml of water and 100 ml of solvent mixture, sonicate for 15 minutes and shake for 30 minutes. Dilute to 250 ml with the solvent mixture, centrifuge and dilute 25.0 ml of the supernatant to 200 ml with the solvent mixture.
Reference solution (a). A solution containing 0.003 per cent w/v of benzothiadiazine impurity A RS, 0.006 per cent w/v of hydrochlorothiazide RS, 0.008 per cent w/v of valsartan RS and 0.02 per cent w/v of valsartan impurity B RS in the solvent mixture. Reference solution (b). Dilute 5.0 ml of reference solution (a) to 100 ml with the solvent mixture. Reference solution (c). Dilute 10 ml of reference solution (b) to 100 ml with the solvent mixture. Inject reference solutions (b) and (c). The test is not valid unless in the chromatogram obtained with reference solution (b), the resolution between valsartan impurity B and valsartan and between benzothiadiazine impurity A and hydrochlorothiazide is not less than 1.4. The relative standard deviation for replicate injections is not more than 10 per cent in the chromatogram obtained with reference solution (c). Inject reference solutions (a), (b) and (c) and the test solution. The area of the peak due to benzothiadiazine impurity A is not more than 1.0 per cent; the area of any secondary peak other than valsartan impurity A is not more than 0.2 per cent; and the sum of areas of all the secondary peaks other than valsartan impurity A is not more than 1.3 per cent. (Valsartan impurity A is the enantiomer of valsartan and coelutes with valsartan in this |
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| 12. | Assay: | ||||
| Each uncoated tablet contains: | Limit | ||||
| Claim | In mg | In % | |||
| Valsartan IP | 80 mg | ||||
| Hydrochlorothiazide IP | 12.5 | ||||
| Pack size: | |||||
| Shelf life | 24 months | ||||
| Storage: Store in a cool, dark & dry place. | |||||
| Reference: As per I.P. | |||||
SPECIFICATION OF STABILITY ANALYSIS
| S.NO. | TESTS | SPECIFICATIONS | REFERENCE | ||
| 1. | Description | ||||
| 2. | Average weight | ||||
| 3. | Uniformity of weight | ||||
| 4. | Identification
|
A. Determine by thin-layer chromatography ,coating the plate with silica gel GF254.
Mobile phase. A mixture of 80 volumes of ethyl acetate,20 volumes of dehydrated alcohol and 10 volumes of a 25 percent w/v solution of ammonium hydroxide.
Test solution. Disperse a quantity of powdered tablets containing about 20 mg of valsartan in 100 ml of acetone, sonicate for 15 minutes and filter. Reference solution. A solution equivalent to test concentrations of valsartan IPRS and hydrochlorothiazide IPRS in acetone .Apply to the plate 2 µl of each solution. Allow the mobile phase to rise 7 cm. Dry the plate in a current of warm air and examine under ultraviolet light at 254 nm. The principal spot in the chromatogram obtained with the test solution corresponds to that in the chromatogram obtained with the reference solution. B. In the Assay, the retention time of the principal peak in the chromatogram obtained with the test solution corresponds to that in the chromatogram obtained with the reference solution.
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| 5. | Hardness | ||||
| 6. | Disintegration Time | NMT | |||
| 7. | Friability | NMT | |||
| 8. | Dissolution | NLT 80% | |||
| 9. | Related Substance | Determine by liquid chromatography, as described under Assay using the following
solutions. Solvent mixture. Equal volumes of acetonitrile and water. Test solution. Disperse a quantity of powdered tablets containing about 62.5 mg of Hydrochlorothiazide with 5.0 ml of water and 100 ml of solvent mixture, sonicate for 15 minutes and shake for 30 minutes. Dilute to 250 ml with the solvent mixture, centrifuge and dilute 25.0 ml of the supernatant to 200 ml with the solvent mixture.
Reference solution (a). A solution containing 0.003 per cent w/v of benzothiadiazine impurity A RS, 0.006 per cent w/v of hydrochlorothiazide RS, 0.008 per cent w/v of valsartan RS and 0.02 per cent w/v of valsartan impurity B RS in the solvent mixture. Reference solution (b). Dilute 5.0 ml of reference solution (a) to 100 ml with the solvent mixture. Reference solution (c). Dilute 10 ml of reference solution (b) to 100 ml with the solvent mixture. Inject reference solutions (b) and (c). The test is not valid unless in the chromatogram obtained with reference solution (b), the resolution between valsartan impurity B and valsartan and between benzothiadiazine impurity A and hydrochlorothiazide is not less than 1.4. The relative standard deviation for replicate injections is not more than 10 per cent in the chromatogram obtained with reference solution (c). Inject reference solutions (a), (b) and (c) and the test solution. The area of the peak due to benzothiadiazine impurity A is not more than 1.0 per cent; the area of any secondary peak other than valsartan impurity A is not more than 0.2 per cent; and the sum of areas of all the secondary peaks other than valsartan impurity A is not more than 1.3 per cent. (Valsartan impurity A is the enantiomer of valsartan and coelutes with valsartan in this |
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| 10. | Assay: | ||||
| Each uncoated tablet contains: | Limit | ||||
| Claim | In mg | In % | |||
| Valsartan IP | 80 mg | ||||
| Hydrochlorothiazide IP | 12.5 | ||||
| Pack size: | |||||
| Shelf life | 24 months | ||||
| Storage: Store in a cool, dark & dry place. | |||||
| Reference: As per I.P. | |||||
*Related Substance: once in a year.
*Microbial Limit Test: once in a year .
| S.NO. | TESTS | SPECIFICATIONS | REFERENCE | ||
| 1. | Description | ||||
| 2. | Average weight | ||||
| 3. | Uniformity of weight | ||||
| 4. | Identification
|
A. Determine by thin-layer chromatography ,coating the plate with silica gel GF254.
Mobile phase. A mixture of 80 volumes of ethyl acetate,20 volumes of dehydrated alcohol and 10 volumes of a 25 percent w/v solution of ammonium hydroxide.
Test solution. Disperse a quantity of powdered tablets containing about 20 mg of valsartan in 100 ml of acetone, sonicate for 15 minutes and filter. Reference solution. A solution equivalent to test concentrations of valsartan IPRS and hydrochlorothiazide IPRS in acetone .Apply to the plate 2 µl of each solution. Allow the mobile phase to rise 7 cm. Dry the plate in a current of warm air and examine under ultraviolet light at 254 nm. The principal spot in the chromatogram obtained with the test solution corresponds to that in the chromatogram obtained with the reference solution. B. In the Assay, the retention time of the principal peak in the chromatogram obtained with the test solution corresponds to that in the chromatogram obtained with the reference solution.
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| 5. | Hardness | ||||
| 6. | Disintegration Time | NMT | |||
| 7. | Dimension |
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| 8. | Friability | NMT | |||
| 9. | Dissolution | NLT 80% | |||
| 10. | Leak Test | Should be Pass | |||
| 11. | Related Substance | Determine by liquid chromatography, as described under Assay using the following
solutions. Solvent mixture. Equal volumes of acetonitrile and water. Test solution. Disperse a quantity of powdered tablets containing about 62.5 mg of Hydrochlorothiazide with 5.0 ml of water and 100 ml of solvent mixture, sonicate for 15 minutes and shake for 30 minutes. Dilute to 250 ml with the solvent mixture, centrifuge and dilute 25.0 ml of the supernatant to 200 ml with the solvent mixture.
Reference solution (a). A solution containing 0.003 per cent w/v of benzothiadiazine impurity A RS, 0.006 per cent w/v of hydrochlorothiazide RS, 0.008 per cent w/v of valsartan RS and 0.02 per cent w/v of valsartan impurity B RS in the solvent mixture. Reference solution (b). Dilute 5.0 ml of reference solution (a) to 100 ml with the solvent mixture. Reference solution (c). Dilute 10 ml of reference solution (b) to 100 ml with the solvent mixture. Inject reference solutions (b) and (c). The test is not valid unless in the chromatogram obtained with reference solution (b), the resolution between valsartan impurity B and valsartan and between benzothiadiazine impurity A and hydrochlorothiazide is not less than 1.4. The relative standard deviation for replicate injections is not more than 10 per cent in the chromatogram obtained with reference solution (c). Inject reference solutions (a), (b) and (c) and the test solution. The area of the peak due to benzothiadiazine impurity A is not more than 1.0 per cent; the area of any secondary peak other than valsartan impurity A is not more than 0.2 per cent; and the sum of areas of all the secondary peaks other than valsartan impurity A is not more than 1.3 per cent. (Valsartan impurity A is the enantiomer of valsartan and coelutes with valsartan in this |
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| 12. | Assay: | ||||
| Each uncoated tablet contains: | Limit | ||||
| Claim | In mg | In % | |||
| Valsartan IP | 160 mg | ||||
| Hydrochlorothiazide IP | 12.5 | ||||
| Pack size: | |||||
| Shelf life | 24 months | ||||
| Storage: Store in a cool, dark & dry place. | |||||
| Reference: As per I.P. | |||||
SPECIFICATION OF STABILITY ANALYSIS
| S.NO. | TESTS | SPECIFICATIONS | REFERENCE | ||
| 1. | Description | ||||
| 2. | Average weight | ||||
| 3. | Uniformity of weight | ||||
| 4. | Identification
|
A. Determine by thin-layer chromatography ,coating the plate with silica gel GF254.
Mobile phase. A mixture of 80 volumes of ethyl acetate,20 volumes of dehydrated alcohol and 10 volumes of a 25 percent w/v solution of ammonium hydroxide.
Test solution. Disperse a quantity of powdered tablets containing about 20 mg of valsartan in 100 ml of acetone, sonicate for 15 minutes and filter. Reference solution. A solution equivalent to test concentrations of valsartan IPRS and hydrochlorothiazide IPRS in acetone .Apply to the plate 2 µl of each solution. Allow the mobile phase to rise 7 cm. Dry the plate in a current of warm air and examine under ultraviolet light at 254 nm. The principal spot in the chromatogram obtained with the test solution corresponds to that in the chromatogram obtained with the reference solution. B. In the Assay, the retention time of the principal peak in the chromatogram obtained with the test solution corresponds to that in the chromatogram obtained with the reference solution.
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| 5. | Hardness | ||||
| 6. | Disintegration Time | NMT | |||
| 7. | Friability | NMT | |||
| 8. | Dissolution | NLT 80% | |||
| 9. | Related Substance | Determine by liquid chromatography, as described under Assay using the following
solutions. Solvent mixture. Equal volumes of acetonitrile and water. Test solution. Disperse a quantity of powdered tablets containing about 62.5 mg of Hydrochlorothiazide with 5.0 ml of water and 100 ml of solvent mixture, sonicate for 15 minutes and shake for 30 minutes. Dilute to 250 ml with the solvent mixture, centrifuge and dilute 25.0 ml of the supernatant to 200 ml with the solvent mixture.
Reference solution (a). A solution containing 0.003 per cent w/v of benzothiadiazine impurity A RS, 0.006 per cent w/v of hydrochlorothiazide RS, 0.008 per cent w/v of valsartan RS and 0.02 per cent w/v of valsartan impurity B RS in the solvent mixture. Reference solution (b). Dilute 5.0 ml of reference solution (a) to 100 ml with the solvent mixture. Reference solution (c). Dilute 10 ml of reference solution (b) to 100 ml with the solvent mixture. Inject reference solutions (b) and (c). The test is not valid unless in the chromatogram obtained with reference solution (b), the resolution between valsartan impurity B and valsartan and between benzothiadiazine impurity A and hydrochlorothiazide is not less than 1.4. The relative standard deviation for replicate injections is not more than 10 per cent in the chromatogram obtained with reference solution (c). Inject reference solutions (a), (b) and (c) and the test solution. The area of the peak due to benzothiadiazine impurity A is not more than 1.0 per cent; the area of any secondary peak other than valsartan impurity A is not more than 0.2 per cent; and the sum of areas of all the secondary peaks other than valsartan impurity A is not more than 1.3 per cent. (Valsartan impurity A is the enantiomer of valsartan and coelutes with valsartan in this |
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| 10. | Assay: | ||||
| Each uncoated tablet contains: | Limit | ||||
| Claim | In mg | In % | |||
| Valsartan IP | 160 mg | ||||
| Hydrochlorothiazide IP | 12.5 | ||||
| Pack size: | |||||
| Shelf life | 24 months | ||||
| Storage: Store in a cool, dark & dry place. | |||||
| Reference: As per I.P. | |||||
*Related Substance: once in a year.
*Microbial Limit Test: once in a year .
STANDARD TESTING PROCEDURE
- Description: Visual
- Average Weight: Check weight of 20 tablets at randomly and calculate the average weight by formula.
Average weight (mg) = wt of 20 tablets (gm) x 1000
20
- Uniformity of weight:
Weigh 20 tablets selected at random and calculate the average weight. Not more than two of the individual weights deviate from the average weight by more than the percentage shown in table.
Tablets were weighed individually and the percentage of deviation of its weight from the average weight was determined for each tablet. Formula to calculate the percentage of deviation.
Deviation (%) = Weight of each tablet – Average weight x 100
Average weight
| Average weight of tablets | Percentage deviation |
| More than 80mg but Less than 250mg | ±7.5% |
- Identification Test:
- Determine by thin-layer chromatography ,coating the plate with silica gel GF254.
Mobile phase. A mixture of 80 volumes of ethyl acetate,20 volumes of dehydrated alcohol and 10volumes of a 25 percent w/v solution of ammonium hydroxide.
Test solution. Disperse a quantity of powdered tablets containing about 20 mg of valsartan in 100 ml of acetone, sonicate for 15 minutes and filter.
Reference solution. A solution equivalent to test concentrations of valsartan IPRS and hydrochlorothiazide IPRS
in acetone .Apply to the plate 2 µl of each solution. Allow the mobile phase to rise 7 cm. Dry the plate in a current of warm air and examine under ultraviolet light at 254 nm. The principal spot in the chromatogram obtained with the test solution corresponds to that in the chromatogram obtained with the reference solution.
- In the Assay, the retention time of the principal peak in the chromatogram obtained with the test solution corresponds to that in the chromatogram obtained with the reference solution.
5.0) Hardness:
The standard method used for tablet hardness testing is compression testing. The tablet is placed between two jaws that crush the tablet. The machine measures the force applied to the tablet and detects when it fractures.
6.0) Disintegration Time:
Unless otherwise stated in the individual monograph, introduce one tablet into each tube and add a disc to each tube. The assembly is suspended in the liquid medium in a suitable vessel, preferably a 1-litre beaker. The volume of liquid is such that the wire mesh at its highest point is at least 15mm below the surface of the liquid, and at its lower point is at least 25mm above the bottom of the beaker. At no time should the top of the basket-rack assembly become submerged. There is a thermostatic arrangement for heating the liquid and maintaining the temperature at 37±2°.
If 1 or 2 tablets fail to disintegrate, repeat the test on 12 additional tablets; not less than 16 of the total of 18 tablets tested disintegrate.
If the tablets adhere to the disc and the preparation under examination fails to comply, repeat the test omitting the disc. The preparation complies with the test if all the tablets in the repeat test disintegrate.
7.0) Dimension of Tablet:
Diameter and thickness are determined by vernier calliper in mm.
8.0) Friability:
The test is applicable to compressed tablets and is intended to determine the physical strength of tablets. Tablets with a unit weight equal to or less than 650 mg, take a sample of whole tablets corresponding as near as possible to 6.5 g. For tablets with a unit weight of more than 650mg, take a sample of 10 whole tablets. The tablets should be carefully dedusted prior to testing. Accurately weigh the tablet sample, and place the tablets in the drum. Rotate the drum 100 times and remove the tablets. Remove any loose dust from the tablets as before, and accurately weigh.
The test is run only once unless the results are difficult to interpret or if the weight loss is greater than the target value, in which case, the test is repeated twice and the mean of the three tests is determined.
% Friability = W1 – W2 X 100
W1
W1= Initial weight W2= Final weight
A maximum loss of weight (From a single test or from the mean of three tests) not greater than 1.0 percent is acceptable for most tablets.
If obviously cracked, chipped or broken tablets are present in the sample after tumbling, the sample fails the test.
9.0) Dissolution:
Apparatus: Paddle
Medium: 1000 ml of Phosphate buffer
Time: 30 minutes
Speed: 50 rpm
Withdraw a suitable volume of the medium and filter. Measure
the absorbance of the filtered solution, suitably diluted with
the medium if necessary, at the maximum at about 250 nm for
valsartan and 272 Dm for hydrochlorothiazide (2.4.7). Calculate
the content of C24H29N503 and C7H8CIN304S2 in the medium
from the absorbance obtained from a solution of known
concentration of valsartan RS and hydrochlorothiazide RS
in the same medium.
Calculate the content of valsartan dissolved by the formula:
(AT2XA1 per cent H272nm)-(AT1 XA1 per cent H250nm)
———————————————————————————————————————————————————————– X12,500
(A1 per cent V250nm XA1 per cent H272nm)-(A1 per cent V272X A1 per cent H250nm)
Calculate the content of hydrochlorothiazide dissolved by the formula:
(AT1 X A1 per cent V250nm)-(AT2 XA1 per cent V272nm)
- ——————————————————————————————————————————————————- X80,000
(A1 per cent H272 nm X A1 per cent V250nm)-(A1 per cent H250nm– A1 per cent V272nm)
where,
AT1 = absorbance of the test solution at 272 nm,
AT2 = absorbance of the test solution at 250 nm,
A1 per cent V 272 nm = absorptivity (1 per cent, 0.2 cm, 272 nm) of valsartan in medium
A1 per cent V250nm = absorptivity (1 per cent, 0.2 cm, 250 nm) of valsartan in medium
A1 per cent H272 nm = absorptivity (1 per cent, 0.2 cm, 272 nm) of hydrochlorothiazide in medium
A1 per cent H250nm = absorptivity (1 per cent, 0.2 cm, 250 nm) of hydrochlorothiazide in medium
10.0) Leak test:
The apparatus is used to test for the integrity of packed strips, blisters and Alu-Alu Blister pack containing tablets. Ensure apparatus bath is filled with purified water upto mark indicated and add 0.5% crystal violet solution in water. Samples are placed into the desiccators and the lid is placed in position. The pump starts to produce a vacuum 15inHg inside the desiccators and the vacuum is held for 1 minute. The sample remains at the required vacuum level for given time interval buzzer will sound after time is over and will cut off the vacuum pump. As the package is immersed in a colored dye solution the venting of the desiccators will allow any holes to be penetrated by the dye and the contents of the flexible packaging will also be stained with the same coloring material.
Examine all the strips for any leakage by opening the pockets manually. If anyone pocket shows evidence of leakage, reject the sample, stop the Blister / Strip machine and immediately take corrective action.
11.0) Related Substance:
Determine by liquid chromatography, as described under Assay using the followingsolutions.
Solvent mixture. Equal volumes of acetonitrile and water.
Test solution. Disperse a quantity of powdered tablets containing about 62.5 mg of Hydrochlorothiazide with 5.0 ml of water and 100 ml of solvent mixture, sonicate for 15 minutes and shake for 30 minutes. Dilute to 250 ml with the solvent mixture, centrifuge and dilute 25.0 ml of the supernatant to 200 ml with the solvent mixture.
Reference solution (a). A solution containing 0.003 per cent w/v of benzothiadiazine impurity A RS, 0.006 per cent w/v of hydrochlorothiazide RS, 0.008 per cent w/v of valsartan RS and 0.02 per cent w/v of valsartan impurity B RS in the solvent mixture.
Reference solution (b). Dilute 5.0 ml of reference solution (a) to 100 ml with the solvent mixture.
Reference solution (c). Dilute 10 ml of reference solution (b) to 100 ml with the solvent mixture.
Inject reference solutions (b) and (c). The test is not valid unless in the chromatogram obtained with reference solution
(b) the resolution between valsartan impurity B and valsartan and between benzothiadiazine impurity A and
hydrochlorothiazide is not less than 1.4. The relative standard deviation for replicate injections is not more than 10 per cent in the chromatogram obtained with reference solution (c). Inject reference solutions (a), (b) and (c) and the test solution.
The area of the peak due to benzothiadiazine impurity A is not more than 1.0 per cent; the area of any secondary peak other than valsartan impurity A is not more than 0.2 per cent; and the sum of areas of all the secondary peaks other than valsartan impurity A is not more than 1.3 per cent. (Valsartan impurity A is the enantiomer of valsartan and coelutes with valsartan in this
12.0) Assay: Determined by liquid chromatography.
Test solution: Add a quantity of whole tablets containing 0.1 g of baclofen to 25 ml of a mixture of 100 volumes of water and 1 volume of glacial acetic acid and disperse with the aid of ultrasound. Dilute to 50.0 ml with methanol, filter and use the filtration.
Reference solution: A 0.2 per cent w/v solution of baclofen reference standard in a mixture of 100 volumes of methanol, 100 volumes of water and 1 volume of glacial acetic acid.
Chromatographic system:
- A stainless steel column 20 cm X 4.6 mm packed with octadecylsilyl silica gel (10µm) (such as Nucleosil C18)
- Mobile phase: 0.01M sodium hexanesulphonate in a mixture of 100 volumes of methanol, 100 volumes of water and 1 volume of G.A.A.
- Flow rate: 2 ml per minute,
- Spectrophotometer set at 265 nm,
- Injection volume: 20 µl
Inject the reference solution. The test is not valid unless the relative standard deviation for replications is not more than 2.0 per cent.
Calculate the content of Baclofen in tablets.
Formula:
Area of Test STD Wt.(mg) 50 Potency
—————–X—————–X——————X———–X Average wt.
Area of STD 50 Test Wt.(mg) 100
Alternative Method: By UV Spectrophotometer
Test Solution: Weigh and powder 20 tablets. Weight sample equivalent to 10 mg of Baclofen 100 ml volumetric flask add 20 ml 0.1 M NaOH into it and sonicate to dissolve the test sample. Make up to mark with 0.1 M NaOH. Filter and dilute 5 ml to 50 ml with 0.1 M NaOH.
Reference Solution: Weigh 50 mg of reference standard of Baclofen in 100 ml of volumetric flask. Add 20 ml 0.1 M NaOH into it and sonicate to dissolve. Make up to mark with 0.1 M NaOH. Dilute 1 ml of this solution to 50 ml with 0.1 M NaOH.
Check Absorbance of test as well as reference standard at 220 nm in UV Spectrophotometer.
Calculate the content of Baclofen in the tablets.
Formula:
Abs. of Test STD Wt.(mg) 1 100 50 Potency
—————–X————–X——-X——————X——–X———–X Average wt.
Abs. of STD 100 50 Test Wt.(mg) 5 100
Acceptance criteria: 90.0%-110.0%
13.0) MICROBIOLOGICAL PURITY:
Perform the test according to requirements of IP,
Total aerobic Microbial count (TAMC): NMT 103 CFU/g
Total combined yeasts/Moulds count (TYMC): NMT 102 CFU/g
Pathogens: in 1gm drug.
Escherichia Coli – Should be absent
Pseudomonas aeroginosa – Should be absent
Salmonella – Should be absent
Staphylococcus aureus– Should be absent
Abbreviations:
Wt.: Weight
ml: Millilitre
inHg: Inch of Mercury
O.P.A: Orthophosphoric acid
G.A.A: Glacial acetic acid
mg: Milligram
STD: Standard
rpm: Rotations per minute
NaOH: Sodium Hydroxide
HCl: Hydrochloric acid
