- Erythromycin
- Deflazacort
- Erythromycin Stearate
- Erythromycin Estolate
- Erythromycin Ethyl Succinate
- Roxithromcin
- Azithromycin Dihydrate
- Clarithomycin
- Betamethasone Sodium Phosphate
- Betamethasone Valerate
- Betamethasone Di Propionate
- Beclomethasone Di Propionate
- Dexamethasone Sodium Phosphate
- Mometasone Furoate
- Erythromycin Phosphate
- Azithomycin
- Azithomycin Taste Mask Granules
- Azithomycin Monohydrate
- Clarithromycin Taste Mask Granules
- Betamethasone
- Clobetasol Propionate
- Clobetasol Butyrate
- Dexamethasone
- Hydrocortisone
- Methylprednisolone
- Methylprednisolone Acetate
- Prednisolone
- Prednisolone Acetate
Erythromycin
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White crystalline powder | White or slightly yellow powder or
colourless or slightly yellow crystals,slightly hygroscopic. |
| 2 - Solubility : | Complies | Slightly soluble in water,freely
soluble in alcohol, soluble in methanol. |
| 3 - Identification Test(s) : | Complies | As per BP |
| 4 - pH : | 9.3 | 8.0 to 10.5 |
| 5 - Related Substance : | Complies | As Per BP |
| 6 - Specific optical rotation: | -75.3° | -71° to -78° |
| 7 - Water : | 4.2% | NMT 6.5% |
| 8 - Heavy Metals | Complies | As Per BP |
| 9 - Sulphated Ash | 0.05% | NMT0.2% |
| 10 - Assay : | 942.5 Units/mg | NLT 920 Units/mg |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White crystalline powder | White or slightly yellow powder or
colourless or slightly yellow crystals,slightly hygroscopic. |
| 2 - Solubility : | Complies | Slightly soluble in water,freely
soluble in alcohol, soluble in methanol. |
| 3 - Identification Test(s) : | Complies | A. By IR |
| 4 - Specific optical rotation: | -74.61° | -71° to -78° |
| 5 - Crystallinity | Complies | As Per USP |
| 6 - Water : | 4.54% | NMT 10.0% |
| 7 - Residue on ignition : | 0.07% | NMT0.2% |
| 8 - Organic impurities : | Complies | As Per USP |
| 10 - Assay : | 99.6% | Sum of Erythromycin A,
erythromycin B and Erythromycin C is NLT - 85.0% and NMT - 100.5% |
Deflazacort
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White powder | A White To Creamy White, Crystalline Powder, Odourless |
| 2 - Solubility : | Complies | Very Soluble In Chloroform and In Methylene Dichloride, Soluble In Acetone And In Methanol, Practically insoluble in Water |
| 3 - Identification Test(s) : | Complies | A. By IR |
| Complies | B. By TLC | |
| 4 - Specific Rotation : | '+ 63.74°C | + 58° to +68° |
| 5 - Melting Range : | 256ºC | About 255ºC |
| 6 - Related Substance By HPLC : | 0.15 % | Individual Impurity Nmt 0.5 % |
| 0.33 % | Total Impurity Nmt 1.5 % | |
| 7 - Loss On Drying | 0.27 % W/W | Between 97.0 and 102.0 % |
| 8 - Assay On Dried Basis By HPLC : | 2.74% | Between 97.0 and 102.0 % |
| 9 - % Of Transmittance At 650 NM : | 100.01% | Not Less Than 97.0 % |
| 10 - CV At 400 NM (1.0%W/V Soln. In MDC) | 1.4% | Not More Than 0.02 Absorption |
Erythromycin Stearate
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White crystalline powder | White crystalline powder. |
| 2 - Solubility : | Complies | Practically insoluble in water
soluble in acetone, in ethanol and in methanol.Solutions in these solvents may be opalescent. |
| 3 - Identification Test(s) : | Complies | A. By TLC |
| Complies | B. A red colour produced. | |
| Complies | C. A yellow colour develops. | |
| 4 - pH : | 8.49 | 7.0 to 10.5 |
| 5 - Related Substance By TLC : | Complies | Complies as Per IP |
| 6 - Erythromycin Stearate : | 87.31% | NLT 84% |
| 7 - Free Stearic Acid : | 12.07% | NMT 14.0% |
| 8 - Erythromycin Stearate + Free Stearic Acid | 99.38% | 98.0 % to 103 % |
| 9 - Water : | 2.51% | NMT 4.0% |
| 10 - Sulphated Ash | 0.05% | NMT 0.5% |
| 11 - Assay : (OAB) | 623.10 Units/mg | NLT 600 Units/mg |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White crystalline powder | White crystalline powder. |
| 2 - Solubility : | Complies | Practically insoluble in water
soluble in acetone, in ethanol and in methanol.Solutions in these solvents may be opalescent. |
| 3 - Identification Test(s) : | Complies | A. By TLC |
| Complies | B. A red colour produced. | |
| Complies | C. A yellow colour develops. | |
| 4 - pH : | 8.42 | 7.0 to 10.5 |
| 5 - Erythromycin Stearate : | 87.57% | NLT 84% |
| 6 - Free Stearic Acid : | 12.16% | NMT 14.0% |
| 7 - Erythromycin Stearate + Free Stearic Acid | 99.73% | 98.0 % to 103 % |
| 8 - Water : | 2.73% | NMT 4.0% |
| 9 - Sulphated Ash | 0.06% | NMT 0.5% |
| 10 - Assay : (OAB) | 622.08 Units/mg | NLT 600 Units/mg |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White crystalline powder | White or almost white crystalline powder. |
| 2 - Solubility : | Complies | Practically insoluble in water Soluble in alcohol, in chloroform, in methanol and in ether. |
| 3 - Identification Test(s) : | Complies | A. By IR |
| 4 - Related Substances : | Complies | As Per USP |
| 5 - Water : | 2.4% | NMT 4.0% |
| 6 - Erythromycin Stearate : | 87.57% | NLT 84% |
| 7 - Residue on Ignition : | 0.06% | NMT 1.0% |
| 8 - Crystallinity : | Complies | Meets the requirement |
| 9 - Assay : (OAB) | 60.9% | Sum of contents of - Erythromycin A, Erythromycin B andErythromycin C NLT 55.0% |
| Complies | Erythromycin B NMT 12.0% | |
| Complies | Erythromycin C NMT 5.0% |
Erythromycin Estolate
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White powder | White crystalline powder. |
| 2 - Solubility : | Complies | Freely soluble in chloroform in ethanol & in acetone,Practically insoluble in water and in 2M hydrochloric acid. |
| 3 - Identification Test(s) : | Complies | A. By IR |
| Complies | D. A yellow colour develops in HCL acid | |
| 4 - pH : | 6.25 | 5.5 to 7.0 |
| 5 - Related Substance By TLC : | Complies | Complies as Per BP |
| 6 - Content of dodecyl sulphate : | 24.1% | 23.0% to 25.5% |
| 7 - Water : | 3.1% | NMT 4.0% |
| 8 - Sulphated Ash | 0.05% | NMT 0.5% |
| 9 - Assay : (OAB) | 643.7 Units/mg | NLT 610 Units/mg |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White crystalline powder | White crystalline powder. |
| 2 - Solubility : | Complies | Practically insoluble in water
soluble in acetone freely soluble in ethanol (96%). |
| 3 - Identification Test(s) : | Complies | A. By IR - Confirms to the
spectrum of Erythromycin Estolate RS |
| 4 - Free erythromycin : | Complies | NMT 3% |
| 5 - Crystallinity : | Complies | Complies as Per USP |
| 6 - Water : | 3.39% | NMT 4.0% |
| 7 - Assay by Microbial : | 641.20 Units/mg | NLT 600 Units/mg |
Erythromycin Ethyl Succinate
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White crystalline powder | White crystalline powder. |
| 2 - Solubility : | Complies | Practically insoluble in water,
Freely soluble in Acetone, in ethanol and in methanol. |
| 3 - Identification Test(s) : | Complies | A. By IR |
| 4 - Related Substance : | Complies | As Per BP |
| 5 - Specific optical rotation: | -77.0˚ | -70.0˚to -82.0˚ |
| 6 - Water : | 2.39% | NMT 3.0% |
| 7 - Free Erithromycin | Complies | NMT 6.0% |
| 8 - Sulphated Ash | 0.05% | NMT 0.3% |
| 9 - Assay : | 80.47 % | Sum of Erothromycin A+B+C |
| Complies | NLT-78.0% | |
| Complies | Erothromycin B NMT-5.0% | |
| Erothromycin C NMT-5.0% |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White crystalline powder | White or almost white crystalline powder,Hygroscopic. |
| 2 - Solubility : | Complies | Practically insoluble in water
freely soluble in acetone Ethanol and in Methanol. |
| 3 - Identification : | Complies | A. By IR |
| 4 - Crystallinity : | Complies | Meets the requirement |
| 5 - X-ray Differection | Complies | As per USP |
| 6 - Related Compounds | Complies | As per USP |
| 7 - Residue on Ignition | 0.46% | NMT 1.0% |
| 8 - Water : | 2.61% | NMT 3.0% |
| 9 - Assay : (OAB) | 80.29% | NLT 76.5% |
Roxythromycin
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White crystalline powder | White crystalline powder. |
| 2 - Solubility : | Complies | Very slightly soluble in water,
freely soluble in acetone ,
in ethanol (95%). and in di chloromethane. |
| 3 - Identification Test(s) : | Complies | A. IR Test |
| Complies | B. HPLC | |
| 4 - Appereance Solution: | Complies | Clear and colourless |
| 5 - Specific optical rotation | -94.34º | -93º to -96º |
| 6- Related Substances: | Complies | As per IP |
| 7 - Heavy metals : | Complies | NMT 10 ppm |
| 8 - Sulphated ash : | 0.07% | NMT 0.1% |
| 9 - Water : | 1.71% | NMT 3.0% |
| 10 - Assay : | 98.71% | 96 % to 102% |
Azithromycin Dihydrate
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description : | White powder | A white or almost white powder . |
| 2 - Solubility : | Complies | Practically insoluble in water
Freely soluble in anhydrous ethanol & in methylene chloride. |
| 3 - Identification Test(s) : | Complies | A. IR Test |
| Complies | B. Retention time of the principal peak obtained with the test solution and reference solution corresponds to each other. |
|
| 4 - Appereance Solution: | Complies | Solution A is Clear |
| 5 - pH : | 9.83 | 9.0 to 11.0 |
| 6 - Specific optical rotation | -46.44° | '-45° to -49° |
| 7 - Water : | 4.26% | 1.8 % to 6.5 % |
| 8 - Sulphated ash : | 0.10% | NMT 0.2% |
| 9 - Heavy metals : | Complies | NMT 25 ppm |
| 10- Related Substances (by HPLC) | Complies | As per IP |
| 11 - Assay (OAB) : | 99.54% | 96% to 102% |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description : | White powder | white or almost white powder . |
| 2 - Solubility : | Complies | Practically insoluble in water,
Freely soluble in anhydrous ethanol & in methylene chloride |
| 3 - Identification Test(s) : | Complies | A. By IR |
| 4 - Appearance of solution : | Complies | Solution S is Clear and colourless |
| 5 - pH : | 9.47 | 9.0 to 11.0 |
| 6 - Specific optical rotation: | -46.52° | '-45° to -49° |
| 7 - Water : | 4.78% | 1.8 % to 6.5 % |
| 8 - Sulphated Ash | 0.06% | NMT 0.2% |
| 9 - Heavy Metals : | Complies | NMT 25 ppm |
| 10 - Related Substances (by HPLC) | Complies | As Per BP |
| 11 - Assay (OAB) | 98.26% | 96% to 102% |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description : | White powder | A white or almost white powder . |
| 2 - Solubility : | Complies | Practically insoluble in water
Freely soluble in anhydrous
ethanol & in methylene chloride. |
| 3 - Identification Test(s) : | Complies | A. IR Test |
| Complies | B. Retention time of the principal peak obtained with the test solution and reference solution corresponds to each other. |
|
| 4- Crystallinity : | Complies | As per USP |
| 5 - pH : | 9.97 | 9.0 to 11.0 |
| 6 - Specific optical rotation | -48.30° | '-45° to -49° |
| 7 - Water : | 4.59% | 4.0 % to 5.0 % |
| 8 - Residue on Ignition: | 0.06% | NMT 0.3% |
| 9 - Heavy metals : | Complies | 25 ppm |
| 10- Related Substances | Complies | As per USP |
| 11 - Assay : | 987.9 µg/mg | 945µg to 1030µg/mg |
Clarithromycin
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | A white or almost white crystalline powder |
A white or almost white crystalline powder |
| 2 - Solubility : | Complies | Practically insoluble in water.Soluble in acetone and Dichloro methane slightly soluble in Methanol. |
| 3 - Identification Test(s) : | Complies | By IR : The infrared absorption
spectrophotometry compare the spectrum with that obtained with Clarithromycin RS or with the reference spectrum of Clarithromycin |
| 4 - Specific optical rotation: | -98.32° | '-94° to -102° |
| 5 - Water : | 0.62% | 2.00% |
| 6 - Heavy Metals | Complies | NMT 20 ppm |
| 7 - Related Substances : | Complies | As Per IP |
| 8 - Assay : | 97.3% | 96% to 102% |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White crystalline powder | White crystalline powder |
| 2 - Solubility : | Complies | Practically insoluble in
water.Soluble in acetone and Dichloro methane; slightly soluble in Methanol. |
| 3 - Identification Test(s) : | Complies | By IR : The infrared absorption
spectrophotometry compare the spectrum with that obtained with Clarithromycin RS or with the reference spectrum of clarithromycin |
| 4 - pH : | 8.87 | 8.0 to 10.0 |
| 5 - Crystallinity | Complies | Meets the requirements |
| 6 - Specific optical rotation: | -98.24° | '-94° to -102° |
| 7 - Water : | 0.62% | 2.00% |
| 8 - Heavy Metals | Complies | NMT 20 ppm |
| 9 - Related Substances (by HPLC) : | Complies | As Per USP |
| 10 - Residue on Ignition | 0.06% | NMT 0.2 % |
| 11 - Assay (OAB) : | 97.2% | 96% to 102% |
Betamethasone Sodium Phosphate
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | A White or almost white powder, odourless, very hygroscopic | A White or almost white
powder, odourless, very hygroscopic |
| 2 - Solubility : | Complies | Freely soluble in water,slightly
soluble in ethanol (95%),
practically insoluble Chloroform,
methylene chloride & Ether. |
| 3 - Identification Test(s) : | Complies | A : Absorbance B : By TLC C, D & E : By Chemical |
| 4 -Apperance of solution : | Complies | As per IP |
| 5 - pH | 8.37 | 7.5 to 9.0 |
| 6 - Specific optical rotation : (OAB) | +101.17° | '+98.0° to +104.0° |
| 7 - Light Absorbance : | Complies | 1.70 to 1.90 |
| 8 - Related Substances : | Complies | As Per IP |
| 9 - Inorganic phosphate : | Complies | As Per IP |
| 10 - Free Betamethasone and other derivaties | Complies | As Per IP |
| 11 - Water : | 7.29% | NMT 8.0% |
| 12 - Assay (OAB): | 98.78% | 96% to 103% |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | white powder | White or almost white powder very hygroscopic. |
| 2 - Solubility : | Complies | Freely soluble in water,slightly
soluble in ethanol (96%),
practically insoluble in methylene chloride. |
| 3 - Identification Test(s) : | Complies | As Per BP |
| 4 -Apperance of solution : | Complies | As per BP |
| 5 - pH | 8.54 | 7.5 to 9.0 |
| 6 - Specific optical rotation : (OAB) | +99.08° | '+98.0° to +104.0° |
| 7 - Related Substances : | Complies | As Per BP |
| 8 - Water : | 6.90% | NMT 8.0% |
| 9 - Assay (OAB): | 98.4% | 96% to 103% |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | Almost white powder | White or almost white powder,very hygroscopic. |
| 2 - Solubility : | Complies | Freely soluble in water,slightly
soluble in ethanol (96%), practically insoluble in methylene chloride. |
| 3 - Identification Test(s) : | Complies | A. By IR |
| Complies | B. By TLC | |
| Complies | C. By Chemical | |
| 4 - Specific optical rotation : (OAB) | +100.04° | '+99.0° to +105.0° |
| 5 - Organic impurity : | Complies | NMT 1.0% |
| 6 - Inorganic impurity : | Complies | NMT 1.0% |
| 7 - Water : | 9.60% | NMT 10.0% |
| 8 - Assay (OAB): | 98.04% | 97.0% to 103.0% |
Betamethasone Valerate
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | A white to creamy white powder | A white to creamy white powder |
| 2 - Solubility : | Complies | Practically soluble in water
and in light petroleum. Freely soluble in chloroform , Soluble in ethanol (95%). |
| 3 - Identification Test(s) : | Complies | A: IR Test |
| Complies | B : By TLC | |
| Complies | C : HPLC | |
| Complies | D : By Chemical | |
| 4 - Specific optical rotation : | +79.81° | '+75.0° to +82.0° |
| 5- Light absorption : | Complies | Complies as per IP |
| 6 - Related Substances : | Complies | Individual ImpurityNMT-1.0% |
| Complies | Total Impurity NMT-2.0% | |
| 7 - Sulphated Ash : | 0.07% | NMT-0.1% |
| 7 - Light Absorbance : | Complies | 1.70 to 1.90 |
| 8 - Loss on Drying : | 0.28% | NMT 0.5% |
| 9 - Assay : (OAB) | 98.22% | 96% to 102% |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White crystalline powder | white or almost white crystalline powder |
| 2 - Solubility : | Complies | Practically soluble in water
freely soluble in acetone & in methylene chloride, sparingly soluble in ethanol (96%). |
| 3 - Identification Test(s) : | Complies | C: IR Test |
| Complies | D: TLC | |
| 4 - Specific optical rotation : | +80.5° | '+75.0° to +82.0° |
| 5 - Related Substances : | Complies | Individual Impurity NMT-1.5% |
| Complies | Greater then 1.0%: NMT 1 peak | |
| Complies | Total Impurity NMT-3.0% | |
| 6 - Residue on Ignition : | 0.05% | NMT 0.2% |
| 7 - Loss on Drying : | 0.3% | NMT 0.5% |
| 8 - Assay : (OAB) | 98.7% | 97% to 103% |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | A White to creamy white powder | A white to creamy white powder |
| 2 - Solubility : | Complies | Practically insoluble in water,
freely soluble in acetone & in methylene chloride, sparingly soluble in ethanol. |
| 3 - Identification Test(s) : | Complies | A. By IR |
| Complies | B. By TLC | |
| 4 - Specific optical rotation : (OAB) | +80.7° | '+75.0° to +82.0° |
| 5 - Related Substances : | Complies | As per USP |
| 6 - Residue on Ignition : | 0.05% | NMT 0.2% |
| 7 - Loss on Drying : | 0.34% | NMT 0.5% |
| 8 - Assay : (ODB) | 98.61% | 97.0% to 103.0% |
Betamethasone Di Propionate
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White crystalline powder | White or almost white, crystalline powder. |
| 2 - Solubility : | Complies | Practically insoluble in water,
freely soluble in acetone & in methylene chloride ,sparingly soluble in ethanol(96 percent). |
| 3 - Identification Test(s) : | Complies | A. Absorbance at 419 nm |
| Complies | B. IR Test | |
| Complies | C. TLC | |
| Complies | D. TLC | |
| Complies | E. By Chemical | |
| Complies | F. By Chemical | |
| 4 - Specific optical rotation: | +66.3° | '+63.0° to +70.0° |
| 5 - Related Substance : | Complies | Single Impurity : NMT 1.50% |
| Complies | Greater than 1.00% : NMT 1 Peak | |
| Complies | Total Impurities : NMT 2.50% | |
| 6 - Loss on Drying : | 0.43% | NMT 1.0% |
| 7 - Assay (OAB): | 98.8% | 97% to 103% |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White crystalline powder | White or almost white, crystalline powder. |
| 2 - Solubility : | Complies | Practically insoluble in water,
freely soluble in acetone & in methylene chloride ,sparingly soluble in ethanol(96 percent). |
| 3 - Identification Test(s) : | Complies | A. Absorbance at 419 nm |
| Complies | B. IR Test | |
| Complies | C. TLC | |
| Complies | D. TLC | |
| Complies | E. By Chemical | |
| Complies | F. By Chemical | |
| 4 - Specific optical rotation: | +66.3° | '+63.0° to +70.0° |
| 5 - Related Substance : | Complies | Single Impurity : NMT 1.50% |
| Complies | Greater than 1.00% : NMT 1 Peak | |
| Complies | Total Impurities : NMT 2.50% | |
| 6 - Loss on Drying : | 0.43% | NMT 1.0% |
| 7 - Assay (OAB): | 98.8% | 97% to 103% |
Beclomethasone Di Propionate
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White crystalline powder | A white to creamy white, crystalline powder, odorless . |
| 2 - Solubility : | Complies | Practically insoluble in water
Freely soluble in anhydrous ethanol & in methylene chloride. |
| 3 - Identification Test(s) : | Complies | A. IR Test Compare the spectrum with that obtained with Beclomethasone Di Propionate RS |
| Complies | B. Chemical Test The liquid gives | |
| Complies | C. HPLC | |
| 4 - Specific optical rotation : | +90.2° | '+88.0° to +94.0° |
| 5 - Light Absorbtion : | Complies | 0.570 to 0.600 |
| 6 - Sulphated Ash : | 0.04% | NMT 0.1% |
| 7 - Loss on Drying : | 0.28% | NMT 0.5% |
| 8 - Assay : | 99.6% | 96.0% to 103.0% |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White crystalline powder | A white or almost white crystalline powder. |
| 2 - Solubility : | Complies | Practically insoluble in water,
Freely soluble in acetone, sparingly soluble in ethanol (96%). |
| 3 - Identification Test(s) : | Complies | A. By IR |
| Complies | B. By Chemical Test | |
| Complies | C. Loss on drying | |
| 4 - Specific optical rotation: | '+110.54° | '+108° to +115° |
| 5 - Loss on Drying : | 0.35% | NMT 0.5% |
| 6 - Related Substances | Complies | As Per BP |
| 7 - Assay : (ODB) | 98.75% | 96% to 102% |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | Creamy White crystalline powder | A white to creamy white , crystalline powder, odorless . |
| 2 - Solubility : | Complies | Practically insoluble in water,
Freely soluble in acetone, sparingly soluble in ethanol (96%). |
| 3 - Identification Test(s) : | Complies | A. By IR |
| 4 - Specific optical rotation: | +89.76° | '+88.0° to +94.0° |
| 5 - Residue on ignition : | 0.05% | NMT 0.1% |
| 6 - Loss on Drying : | 0.32% | NMT 0.5% |
| 7 - Assay : (ODB) | 98.86% | 97% to 103% |
Erythromycin Phosphate
Coming Soon
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Dexamethasone Sodium Phosphate
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White Crystalline Powder,very hygroscopic. | A White or Slightly yellow,crystalline powder, almost odourless,very hygroscopic.Its Shows Polymorphism |
| 2 - Solubility : | Complies | Practically insoluble in Chloroform and
in ether. Freely soluble in water,Slightly soluble in ethanol (95%) very slightly soluble in Dioxan. |
| 3 - Identification Test(s) : | Complies | A. By I.R. |
| Complies | B. UV-Visible absorption Spectophoto metry | |
| Complies | C. By Liquid Chromatography | |
| Complies | D. By Chemical | |
| 4 - pH : | 8.75 | 7.5 to 9.5 |
| 5- Specific optical rotation: | +78.7˚ | +75.0˚ to +83.0˚ |
| 6 - Inorganic phosphates (As PO4) : | Complies | NMT 0.5% w/w |
| 7 - Related Substances : | Complies | Any peak other than principal peak NMT - 0.5% |
| Complies | Sum of all peak other than principal peak NMT - 1.0% | |
| 8 - Ethanol : | 6.8% w/w | NMT-8.0 % w/w |
| 9 - Total Ethanol & Water : | 13.6% w/w | NMT 16.0% w/w |
| 10 - Assay : (OAB & solvent free basis) |
98.8% | Between 97.0% to 103.0% w/w |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | White hygroscopic powder | White or almost white very hygroscopic powder. |
| 2 - Solubility : | Complies | Freely soluble in water,slightly
soluble in ethanol (96%), practically insoluble in methylene chloride. It shows polymorphism. |
| 3 - Identification Test(s) : | Complies | As per BP |
| 4 - Apperance of solution : | Complies | As per BP |
| 5- pH : | 8.67 | 7.5 to 9.5 |
| 6 - Specific optical rotation : (OAB) | +77.2° | '+75.0° to +83.0° |
| 7 - Related substances : | Complies | As per BP |
| 8 - Inorganic phosphates : | Complies | NMT - 1.0% |
| 9 - Ethanol : | Complies | NMT- 3.0% |
| 10 - Ethanol & Water | 11.7% | NMT - 13.0% |
| 11 - Assay (OAB) : | 98.9% | 97.0% to 103.0% |
Mometasone Furoate
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | Almost white powder. | White or almost white powder. |
| 2 - Solubility : | Complies | Soluble in acetone & in dichloro
methane.Slightly soluble in
ethanol. Practically insoluble in water. |
| 3 - Identification Test(s) : | Complies | A: IR Test |
| 4 - Specific optical rotation: | +50.3° | +50.0° to +55.0° |
| 5 - Related Substances : | Complies | Single impurity NMT 0.3% |
| Complies | Total impurity NMT 0.6% | |
| 6 - Heavy Metals | Complies | NMT 30 ppm |
| 7 - Sulphated Ash : | 0.05% | NMT-0.1% |
| 8 - Loss on Drying : | 0.31% | NMT 0.5% |
| 9 - Assay : (ODB) | 99.4% | 97% to 102% |
| TEST | OBSERVATIONS | SPECIFICATIONS |
|---|---|---|
| 1 - Description or appearance : | A off white powder | A white to off white powder. |
| 2 - Solubility : | Complies | Soluble in acetone & in dichloro methane.Slightly soluble in ethanol.Practically insoluble in water. |
| 3 - Identification Test(s) : | Complies Complies |
A: IR Test B:By HPLC |
| 4 - Specific optical rotation : | +58.7° | +56.0° to +62.0° |
| 5 - Organic Impurity (TLC) : | Complies | Complies as per USP |
| 6 - Heavy Metals | Complies | NMT 30 ppm |
| 7 - Residue on Ignition | 0.05% | NMT-0.1% |
| 8 - Loss on Drying : | 0.32% | NMT 0.5% |
| 9 - Assay : | 99.4% | 97% to 102% |