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Our Complete range of products are ACEBROPHYLLINE, Artemisinin, Avobenzone, Bisacodyl and BROMHEXINE.
| Indicators project | Indicators project
Pharmacopoeia technical requirements (%) |
lubon index (%) |
| Effective iodine % | 9.0-12.0 | 19.0-21.0 |
| iodine ion % | ≤6.6 | ≤3.0 |
| residue % | 9.5-11.5 | 9.5-11.5 |
| burning residue % | ≤0.1 | ≤0.05 |
| Dry weight loss % | ≤0.8 | ≤4.0 |
| Arsenic % | ≤0.00015 | _ |
| Heavy metals (pb) % | ≤0.002 | _ |
| Specific rotation | +37.0—+42.0 |
| Photographic flavin | ≤0.025 |
| PH | 5.0-6.5 |
| Free riboflavin | ≤6.0% |
| Loss on drying | ≤7.5% |
| Residue on ignition | ≤25% |
| Volatile organic compounds | Compliance |
| Content | 73.0—79.0% |
| Acidity | 4.0-5.0 |
| Relative substance | ≤0.5% |
| Loss on Drying | 12.0-13.5% |
| Sulphate | ≤0.005% |
| Chloride | ≤0.005% |
| Phosphite | ≤0.3% |
| Heavy Metal | ≤10PPM |
| Residual solvents | ≤0.005% |
| Tests | Specifications | Result |
| Description | grey-brown powder | grey-brown powder |
| Solubility | diffluent in Ach, slightly soluble in methanol,almost insoluble in chloroform | Complies |
| Identification | ||
| HPLC | Comply with standard | Complies |
| A292/A227 | 2.28~2.42 | 2.36 |
| IR | IR should comply with the reference standard spectrum. | Complies |
| citrate | positive | Complies |
| Acidity | 3.0~5.0 | 3.63 |
| Loss on Drying | ≤1.0% | 0.32% |
| Residue on ignition | ≤0.1% | 0.04% |
| Heavy Metals | ≤20ppm | Complies |
| Relevant Impurity | ≤0.5% | 0.28% |
| Methanol | ≤0.3% | 0.02% |
| Methylene dichloride | ≤0.06% | 0.017% |
| N,N-Dimethyl formamide | ≤0.088% | Not detected |
| Assay | 98.5~101.5% | 99.6% |
| Tests | Specifications | Result |
| Description | White or almost white crystalline powder | White crystalline powder |
| Solubility | diffluent in Ach, slightly soluble in methanol,almost insoluble in chloroform | Complies |
| Identification | ||
| HPLC | Comply with standard | Complies |
| A292/A227 | 2.28~2.42 | 2.36 |
| IR | IR should comply with the reference standard spectrum. | Complies |
| citrate | positive | Complies |
| Acidity | 3.0~5.0 | 3.63 |
| Loss on Drying | ≤1.0% | 0.32% |
| Residue on ignition | ≤0.1% | 0.04% |
| Heavy Metals | ≤20ppm | Complies |
| Relevant Impurity | ≤0.5% | 0.28% |
| Methanol | ≤0.3% | 0.02% |
| Methylene dichloride | ≤0.06% | 0.017% |
| N, N-Dimethyl formamide | ≤0.088% | Not detected |
| Assay | 98.5~101.5% | 99.6% |
| Item | Standard | Test Results | |
| Identification | A.H-NMR:Comply with the structure | Complies | |
| B.LC-MS:Comply with the structure | Complies | ||
| C.The IR spectrum of sample should be identical with that of reference standard; | Complies | ||
| D.HPLC-ESI-MS
The 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. |
Complies | ||
| Crystallinity | meets the requirements. | Complies | |
| Loss on drying | ≤2.0% | 0.19% | |
| Heavy metals | ≤10 ppm | <10ppm | |
| Water | ≤1.0% | 0.1% | |
| Sulphated ash | ≤0.5%, determined on 1.0 g. | 0.009% | |
| Related substances | Unspecified impurities: for each impurity | ≤0.10% | <0.10% |
| Total Impurity | ≤0.5% | 0.18% | |
| Purity | ≥99.0% | 99.7% | |
| Assay | 99.0%~101.0% (anhydrous substance). | 99.8% | |
| Microbiological Analysis | |||
| Total plate count | ≤1000cfu/g | Complies | |
| Yeast and Moulds | ≤100cfu/g | Complies | |
| E. Coli. | Absent | Negative | |
| Salmonella | Absent | Negative | |
| S.aureus | Absent | Negative | |
| Storage | Preserve in well-closed, light-resistant and airtight containers. | Complies | |
| ITEMS | SPECIFICATION | |
| APPEARANCE | WHITE OR SLIGHTLY YELLOWISH CRYSTALLINE POWDER | |
| SOLUBILITY | SHOULD MEET THE REQUIREMENT | |
| IR IDENTIFICATION | SHOULD CORRESPOND TO THE RS INFRARED ABSORPTION | |
| APPEARANCE OF SOLUTION | SHOULD MEET THE REQUIREMENT | |
| HEAVY METALS | ≤20PPM | |
| RELATED SUBSTANCE | IMPURITY A | ≤0.15% |
| IMPURITY B | ≤0.15% | |
| IMPURITY C | ≤0.2% | |
| IMPURITY D | ≤0.2% | |
| UPSPECIFIED IMS. | ≤0.1% | |
| TOTAL | ≤1.0% | |
| RESIDUAL SOLVENTS | METHANOL | ≤0.08% |
| ETHANOL | ≤0.08% | |
| METHYLENE DICHLORIDE | ≤0.06% | |
| N-HEXANE | ≤0.029% | |
| ACETIC ACID ETHYL ESTER | ≤0.08% | |
| TOLUENE | ≤0.089% | |
| ACETIC ACID | ≤0.08% | |
| LOSS ON DRYING | ≤0.5% | |
| SULPHATED ASH | ≤0.1% | |
| MELTING POINT | 261℃~263℃ | |
| PARTICLE SIZE | 90%LESS THAN 200UM | |
| ASSAY | 99.0%~101.0% | |
| Item | Standard | Result |
| Appearance | A white or almost white powder | Almost white powder |
| Identification | A: HPLC, retention time of main peak corresponds to that of reference standard
B: IR, IR spectrum of sample corresponds to that of reference standard |
Complies |
| Melting point | 174-178°C | 174-175°C |
| Loss on drying | ≤1.0% | 0.60% |
| Residue on ignition | ≤0.2% | 0.14% |
| Related substances | N-Methyl derivatives≤0.5%
Other single impurity≤0.2% Total impurities≤1.0% |
0.31%
0.12% (RRT=0.542) 0.16% (RRT=1.996) 0.08% (RRT=1.454) 0.7% |
| Assay (on dried basis) | 98.0-101.0% | 98.5% |
| Test Item | Analysis Specification | Result |
| Description | White to off white crystalline powder | Conforms |
| Melting range | 129°C~132°C | 130.8°C-131°C |
| Loss on drying | ≤0.5% | 0.20 % |
| Specific rotation | -58°~-62°(C=1,in CH3OH) | -61.05° |
| Sulphated ash | ≤0.1% | 0.08 % |
| Heavy metals | ≤10ppm | Conforms |
| Chlorides | ≤0.02% | Conforms |
| Sulfates | ≤0.02% | Conforms |
| Fluorine | 14.7%~17.9% | 15.2% |
| Residual solvent | Methanol ≤0.2%
Isopropanol ≤0.2% Ethyl acetate≤0.2% Chloroform ≤0.2% |
0.0%
0.0% 0.0% 0.0% |
| Related substances
(HPLC) |
Single impurity ≤0.2%
Total impurities ≤0.5% |
0.05%
0.08% |
| Assay | ≥99.5% | 99.92% |
| Conclusion | Accordance with the reference | |
| Appearance | White crystalline powder, no visible and dark impurities | |
| Sense of taste | Sweet | |
| Odor | No peculiar smell | |
| Chemical control | GB 13509-2005 | FCC(4) |
| Content of Xylitol | 98.5%~101.0% | 98.5%~101.0% |
| Ash | ≤0.5% | ≤0.1% |
| Loss on Drying | ≤0.5% | ≤0.5% |
| Reducing sugar(as glucose) | ≤0.2% | ≤0.3% |
| Other polyols | ≤2.0% | ≤1.0% |
| Melting point | 92°C~96°C | — |
| Heavy Metal(as Pb) | ≤0.0010% | — |
| Lead(Pb) | ≤0.0001% | ≤0.0001% |
| Arsenic(As) | ≤0.0003% | — |
| Nickel(Ni) | ≤0.0002% | ≤0.0001% |
| Microbiological control | ||
| Total plate count
Mould and Yeast count Coliform bacteria Salmonella |
≤500cfu/g
≤100cfu/g ≤30MPN/100g Negative |
|
Ketan Patel (Neutral Pharma)
Lower Ground Floor, Shop- LG/3, Kashi Plazza Complex, Nr. Chlidren Hospital, Majura Gate, Surat, Gujarat India – 395001
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