Livealth Biopharma Private Limited
Navi Mumbai, Maharashtra
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| Minimum Order Quantity | 1 Kilogram |
| Composition | Colistimethate Sodium |
| Usage/Application | Anti Bacterial |
| Drug Name | Colistimethate Sodium |
| Packaging Size | 1 Kg |
| Packaging Type | HDPE Drum |
| Active Ingredient | Colistimethate Sodium |
| Salt Used | Colistimethate Sodium |
| Cas Number | 8068-28-8 |
| Salt | 8068-28-8 |
| Shelf Life | 3 years |
| Storage | 30 Degree C |
| Dosage Form | Powder |
| Minimum Order Quantity | 100 Kilogram |
| Grade Standard | Technical Grade |
| Physical State | Powder |
| Usage | Commerical |
| Packaging Size | 25KG |
| Packaging Type | Drum packing |
| Minimum Order Quantity | 25 Kilogram |
| Packaging Type | Drum |
| CAS Number | 23672-07-3 |
| Molecular Formula | C15H23N3O4S |
| Molecular Weight | 341.00 |
| Sr.No. | TEST | SPECIFICATION |
| 1. | Description | A white to cream colour powder. |
| 2. | Solubility | Practically insoluble in water Sparingly soluble in methanol., Slightly soluble in alcohol and in methylene chloride, |
| 3. | Identification | |
| a. Melting Point | 182 -188oC | |
| b. BY IR | To Comply | |
| c. By TLC | To Comply | |
| d. By Fluorescence test | The Solution shows blue fluorescence | |
| 4. | Specific Optical Rotation | Between 66o and 69o |
| 5. | Related Substances by HPLC | 1.Any Single impurity Not more than 0.5 % 2.Total Of Impurities Not more than 1.0 % |
| 6. | Chlorides | Not more than 100 ppm |
| 7. | Heavy Metals | Not more than 10 ppm |
| 8. | Loss on Drying | Not more than 0.5 % w/w |
| 9. | Sulphated Ash | Not more than 0.10 % w/w |
| 10. | Assay ( On Dried Basis) | Between 98.5 % to 101.0 % w/w |
| 11. | Residual Solvent | Ethylene Glycol(Not more than 1500 ppm) |
| 12. | Particle Size | 90% Particles are less than 50 micrones 50% Particles are less than 20 micrones 10% Particles are less than 10 micrones |
| 13. | Untapped Density | Report the result |
| 14. | Tapped Density | Report the result |
| Minimum Order Quantity | 25 Kilogram |
| Packaging Type | Drum |
| Usage/Application | Laboratory |
| Physical State | Powder |
| CAS Number | 23672-07-3 |
| Sr.No. | TEST | SPECIFICATION |
| 1. | Description | A white to cream colour powder. |
| 2. | Solubility | Practically insoluble in water Sparingly soluble in methanol., Slightly soluble in alcohol and in methylene chloride, |
| 3. | Identification | |
| a. Melting Point | 182 -188oC | |
| b. BY IR | To Comply | |
| c. By TLC | To Comply | |
| d. By Fluorescence test | The Solution shows blue fluorescence | |
| 4. | Specific Optical Rotation | Between 66o and 69o |
| 5. | Related Substances by HPLC | 1.Any Single impurity Not more than 0.5 % 2.Total Of Impurities Not more than 1.0 % |
| 6. | Chlorides | Not more than 100 ppm |
| 7. | Heavy Metals | Not more than 10 ppm |
| 8. | Loss on Drying | Not more than 0.5 % w/w |
| 9. | Sulphated Ash | Not more than 0.10 % w/w |
| 10. | Assay ( On Dried Basis) | Between 98.5 % to 101.0 % w/w |
| 11. | Residual Solvent | Ethylene Glycol(Not more than 1500 ppm) |
| 12. | Particle Size | 90% Particles are less than 50 micrones 50% Particles are less than 20 micrones 10% Particles are less than 10 micrones |
| 13. | Untapped Density | Report the result |
| 14. | Tapped Density | Report the result |
| Minimum Order Quantity | 25 Kilogram |
| Packaging Type | Drum |
| Usage/Application | Laboratory |
| Melting Point | 235 Deg C to 240 Deg C |
| Color | White crystalline powder |
| TEST | SPECIFICATIONS |
| Characteristics | White crystalline powder |
| Melting Point | 235°C to 240°C |
| Solubility | Alcohol : 100 to 1000 parts Methylene Dichloride : 100 to 1000 parts Water : 1000 to 10000 parts |
| Identification | IR test : Complies with standard Thin Layer Chromatography : Complies with standard Chemical Test : Complies with test Primary Aromatic Amine Test : Complies with amine test Chloride test : Complies with chloride test |
| Appearance of solution | Complies with test |
| uv test | 208 to 211 nm |
| Related substance (HPLC) | Identified impurity: Impurity A : NMT 0.1 % Impurity B : NMT 0.1 % Impurity C : NMT 0.1 % Impurity D : NMT 0.1 % Impurity E : NMT 0.1 % Unknown impurity: Impurity 1 : NMT 0.1 % Impurity 1 : NMT 0.1 % Total impurities : Not More Than 0.3 % |
| Residual solvents | Alcohol : NMT 5000 ppm Toluene : NMT 890 ppm |
| Foreign particles | Not detected |
| Loss on drying | Not More Than : 1.0 % |
| Package Type | Drum |
| Physical State | Powder |
| Specific Optical rotation | Between -125 deg and - deg |
| Color | Yellow |
| TEST | SPECIFICATIONS |
| Description | Light yellow to yellow crystalline powder, slightly hygroscopic |
| Solubility | Soluble in 0.1N sodium hydroxide, sparingly soluble in water and Menthol, slightly soluble in 0.1 N hydrochloric acid in dimethylformimide and in alcohol and practically insoluble in methylene chloride, acetone, ethyl acetate and toluene, insoluble in tert-butyl methyl ether and n-heptane |
| Identification by a) By IR b) HPLC c) Test for chloride d) Specific Optical rotation | The infrared absorption spectrum of the sample should be concordant with that of infread absorption spectrum of standard. The retention time of principal peak of the sample should correspond with that of the working standard Should be positive Should comply to the test |
| Specific optical rotation (On anhydrous basis) | Between -125º and -138º |
| pH (0.2% solution in water) | Between 3.9 and 4.6 |
| Water content (by KF,% w/w) | NMT 4.5 |
| Residue on ignition(% w/w) | NMT 0.1 |
| Appearance of solution | Should comply to the test |
| Sulfate | Should comply to the test |
| Minimum Order Quantity | 25 Kilogram |
| Physical State | Powder |
| Melting Point | 235 Deg C to 240 Deg C |
| Loss on drying | Not More Than 1.0 % |
| Packaging Type | Drum |
| TEST | SPECIFICATIONS |
| Characteristics | White crystalline powder |
| Melting Point | 235°C to 240°C |
| Solubility | Alcohol : 100 to 1000 partsMethylene Dichloride : 100 to 1000 partsWater : 1000 to 10000 parts |
| Identification | IR test : Complies with standardThin Layer Chromatography : Complies with standardChemical Test : Complies with testPrimary Aromatic Amine Test : Complies with amine testChloride test : Complies with chloride test |
| Appearance of solution | Complies with test |
| uv test | 208 to 211 nm |
| Related substance (HPLC) | Identified impurity: Impurity A : NMT 0.1 %Impurity B : NMT 0.1 %Impurity C : NMT 0.1 %Impurity D : NMT 0.1 %Impurity E : NMT 0.1 %Unknown impurity: Impurity 1 : NMT 0.1 %Impurity 1 : NMT 0.1 %Total impurities : Not More Than 0.3 % |
| Residual solvents | Alcohol : NMT 5000 ppmToluene : NMT 890 ppm |
| Foreign particles | Not detected |
| Loss on drying | Not More Than : 1.0 % |
| Packaging Type | Drum |
| Form | Powder |
| Color | A white to creamish colour powder |
| Purity | 99 % |
| TEST | SPECIFICATIONS |
| Description | A white to creamish colour powder. |
| Solubility | Soluble in 100 parts of N,N-Dimethyl Formamide |
| Identificationa) By I.R. b) By HPLC | I.R. spectrum should be identical to that of standard Retention time of the sample peak should corresponds to that of standard |
| Water by K.F. (in DMF) | NMT 8.0%w/w |
| Calcium Content | 3.0% - 5.0%w/w |
| Related Substances (by HPLC)a) Max. Single Impurityb) Total Impurities | NMT 1.0%NMT 2.0% |
| Assay (HPLC,OAB) | NLT 97% w/w |
| Packaging Type | Drum |
| Color | White |
| Melting Point | Between 132 and 137 Degree C |
| Form | Powder |
| TEST | SPECIFICATIONS |
| Solubility | Freely soluble in acetone, in chloroform, in methanol and in toluene, insoluble in water |
| IdentificationA ) Infrared spectrum(In Mineral oil) B ) HPLC | The IR absorption spectrum of the preparation of the test specimen, exhibits maxima only at the same wavelengths as that of a similar preparation of the corresponding Loratadine working standardThe retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation as obtained in the assay |
| Loss on drying (%, w/w) | NMT 0.5 |
| Residue on ignition (%,w/w) | NMT 0.1 |
| Heavy metals (%,w/w) | NMT 0.001 |
| Related compounds (By HPLC)Related compounds ARelated compounds BEach individual unknown impurityTotal impurities | NMT 0.1NMT 0.1NMT 0.1NMT 0.3 |
| Assay By HPLC (%w/w) (On dried basis) | NLT 98.5 and NMT 101.0 |
| Additional TestsResidual solvent/Organic volatile impurities(By GC with HSS, ppm) | Tetrahydrofuran : NMT 500Toluene : NMT 500Di-isopropyl ether : NMT 500Triethylamine : NMT 50 |
| Packaging Type | Drum |
| Color | White |
| Purity | 98 % |
| Physical State | Powder |
| TEST | SPECIFICATIONS |
| Description | A white or almost white powder. |
| Solubility | Practically insoluble in water, freely soluble in Methylene chloride, sparingly soluble in Tetrahydrofuran, very slightly soluble in alcohol |
| IdentificationBy IR | The infra Red absorption spectrum of the finely ground sample in KBr dispersion compressed into a disc should exhibit maxima only at the same wavelengths as that of similar preparation of Itraconazole Working Standard |
| Appearance of solution | A solution of 2 g in 20ml Methylene chloride should be clear and not more intensely coloured than BY6 |
| Optical Rotation | -0.10º to + 0.10º |
| Related substances HPLC | Maximum Single impurity : NMT 0.5%Total Impurities : NMT 1.25% |
| Loss on drying | NMT 0.5%w/w |
| Sulphated Ash | NMT 0.1%w/w |
| Assay on dried basis | NLT 98.5% and NMT 101.5% w/w |
| Purity | 99.9 % |
| Color | White to Brownish |
| Package Type | Drum |
| Physical State | Powder |
| TEST | SPECIFICATIONS |
| Description | White to brownish-white powder |
| Solubility | Freely soluble in dimethylformamide, practically insoluble in water |
Identification
| The 10ug/ml solution in methanol of the Lansoprazole scanned between 200nm and 400nm should exhibit maxima at 285+2nmThe infra red spectrum of the sample dispersed in KBr should exhibit maxima only at the same wavelengths as that of a similar preparation of the working standard |
| Water | NMT 0.1%w/w |
| Residue on ignition | NMT 0.1% w/w |
| Chromatographic Purity by HPLC | Impurity A : NMT 0.4%Impurity B : NMT 0.1%Impurity C : NMT 0.1%Any other individual impurities : NMT 0.1%Total impurities : NMT 0.6% |
| Assay on anhydrous (by HPLC) | Between 98.0% and 102.0% w/w |
| Packaging Type | Drum |
| Color | A white or off white powder |
| Physical State | Powder |
| Melting Point | Between 148 to 152 Deg C |
| TEST | SPECIFICATIONS |
| Description | A white or off white powder. |
| Identification By IR spectrum | Sample spectra should be concordant with Infrared absorption spectrum of Ketoconazole USP working standard |
| Melting range | Between 148 to 152 Deg C |
| Specific rotation | Between -1.0 to +1.0 |
| Loss on drying | Not more than 0.50% under vacuum at 80ºc for 4 hrs. |
| Residue on ignition | NMT 0.10% from 2 gm |
| Heavy metals | NMT 0.002% |
| Chromatographic purity(By TLC) | The principal spot obtained from the test solution has about same size and RF value as that obtained from the Standard solution |
| Organic Volatile impuritiesMethanolEthyl AcetateAcetone | NMT 3000 ppmNMT 5000 ppmNMT 5000 ppm |
| Assay by Autotitrator (On Dried basis) | Between 98.0% and 102.0% |
| Related substancesi) Individual Impurityii) Total Impurity | NMT 0.50% |
| Particle e size | For Information |
| Packaging Type | Drum |
| Usage/Application | Laboratory |
| Color | White |
| Physical State | Powder |
| Package Type | Drum |
| Physical State | Powder |
| Usage/Application | Laboratory |
| Color | White |
| Usage/Application | Laboratory |
| Package Type | Drum |
| Physical State | Powder |
| Storage | Store in Dry and Cool Place |
| Package Type | Drum |
| Physical State | Powder |
| Usage/Application | Laboratory |
| Color | White |
| Minimum Order Quantity | 1 Kilogram |
| Purity | 99% |
| Casno | 95233-18-4 |
| Physical State | Powder |
| Packaging Type | Drum |
| Packaging Type | Drum |
| Color | White crystalline powder |
| Physical State | Powder |
| Purity | 98 % |
| TEST | SPECIFICATIONS |
| Description | A white to off-white crystalline powder |
| Solubility | Freely soluble in methanol, slightly soluble in ethanol |
| IdentificationIR Spectrum | The infra-red absorbance spectrum should be concordant with the reference spectrum |
| Specific Optical Rotation | Between -6.0° and -12.0° on anhydrous basis |
| Related substances by HPLCa) Major individual impurityb) Total impurities | NMT 0.5%NMT 2.0% |
| Heavy metal | NMT 20 ppm |
| Water content (By KFR) | Between 3.0 and 7.0% w/w |
| Asay By HPLC(On Anhydrous Basis) | NLT 98.0% AND NMT 102.0% |
| Description | A white to off-white crystalline powder |
| Solubility | Freely soluble in methanol, slightly soluble in ethanol |
| Purity | 98% |
| Molecular Mass | 548.65 g/mol |
| Chemical Formula | C24H40N2O10S |
| CAS Number | 23031-32-5 |
| Physical State | Powder |
| Package Type | Drum |
| Melting Point | Between 148 to 152 Deg C |
| Usage/Application | Laboratory |