Chloramphenicol BP USP EP
CAS NO.56-75-7
Pharmaceutical raw material
Assay: 99% min
Packing: 25kg/drum
Company Profile:
Jiangxi Runquankang Biotechnology Co., LTD is located in the industrial park of Guantian Town, Chongyi County, Ganzhou City. The company has registered capital of 50 million yuan, covering an area of 8,000 square meters, and owns 99 employees.
The company has a strong competitiveness in domestic and foreign markets with the production of chloramphenicol, heparin sodium and sodium saccharin.Chloramphenicol annual output is 120tons, heparin sodium annual output is 2.5tons, sodium saccharin annual outpurt is 2000tons.
The company has established a perfect quality control system and has a trained QA, QC management team,advanced inspection facilities and testing methods. All the workshop design of the company has reached the national new GMP certification. Meanwhile the core product production workshop is designed and constructed according to the FDA and EU CEP standard.
The company insists on the innovation of science and technology as the driving force.We have established an advanced technology center of the infrastructure and built a relatively perfect technological innovation system. Through independent research and development, technical cooperation,the introduction of digestible absorption and other channels, the company continuously promotes product technology upgrading. The leading product quality and the production technology stands the leading domestic level, possessing the remarkable competitive advantage.
The company established a product marketing center in Nanchang, establishing a wide marketing network, exported chloramphenicol,heparin sodium, sodium sacchrin to more than 30 countries and regions including Singapore, India, Pakistan, Bangladesh, Korea, USA, Brazil and Spain.
Contact information:
Product name | Chloramphenicol | Standard | BP2019 | ||||
Batch No. | 201015 | MFG. Date | OCT 15,2020 | Report Date | 16 OCT, 2020 | ||
Batch size | 500KGS | EXP. Date | OCT 15,2024 | Packing | 25kg/drum | ||
Appearance | A while, greyish-white or yellowish-white, fine, crystalline powder or fine crystals, needles or elongated plates. | A yellowsh-white, fine crystalline powder, needles
| |||||
Solubility | Slightly soluble in water, freely soluble in alcohol and in propylene glycol. Its alcohol solution is dextrorotatory and its ethyl acetate solution is levorotatory. | Qualified | |||||
Identification | Melting range | 149°C ~153°C | 150~151.5°C | ||||
Infrared absorption spectrophotometry | IR spectrophotometry similar to which of Chloramphenicol CRS | Qualified | |||||
Acidity or alkalinity | To 0.1g add 20 ml of carbon dioxide-free water R, shake and add 0.1 ml of bromothymol blue solution Rl. Not more than0.1 ml of 0.02 M hydrochloric acid or 0. 02 M sodium hydroxide is required to change the colour of the indicator. | Qualified | |||||
Specific optical rotation | +18.5°~20.5° | +19.3° | |||||
Related substances | Individaul impurity ≤ 0.5% | 0.24% | |||||
Chorides | ≤0.01% | ＜0.01% | |||||
Loss on drying | ≤0.3% | 0.09% | |||||
Sulfated ash | ≤0.1% | 0.03% | |||||
Assay | 98.0%~102.0% | 99.7% | |||||
Microbial limit | Total aerobic microbial count | ≤10CFU/g | ＜10CFU/g | ||||
Total yeasts and molds count | Absent per g | Absent | |||||
Escherichia coli | Absent per g | Absent | |||||
Pseudomonas aeruginosa & staphylococcus aureus | Absent per g | Absent | |||||
Conclusion | The product complies to BP2019 | ||||||
Packaging and storage | Preserve in well-closed containers, protected from light. | ||||||
