Colistin Sulphate:
CAS No.: 1264-72-8
Purity: 99% min
MF: C52H98N16O13
Properties: A white or almost white powder. Stinkless, bitter and hygroscopic, frelly soluble in water, slightly soluble in methanol and ethandal, Insoluble in acetone, enther, etc. Its free base is slightly soluble in wather. Stable under pH Value 3-7.5
Indications: For use and dosage: Mix throughly with feed at a gradient scale. The recommended dosage level for, swine is 2-40g(under two months of age), is 2-20g(under four months of age), chickens is 2-20g. Basis on 100% active Colistin sulphate.
Potency (dried substance): Not less than 19, 000 IU. /m
Specification:
| Test |
Specification |
| Characteristics |
White or almost white powder |
| Identification |
Meets EP specification |
| PH |
4.0 ~ 6.0 |
| Loss on drying |
≤3.5% |
| Optical rotation |
-63° ~ -73° |
| Sulphated ash |
≤1.0% |
| Sulphate (dried basis) |
16.0% ~ 18.0% |
| Content (Dry basis HPLC) |
Colistin E1-I≤10% |
| |
Colistin E1-7MOA≤10% |
| |
Colistin E3≤10% |
| |
E1+ E2+E3+E1-I+E1-7MOA≥77.0% |
| Related substances |
Any impurity≤4.0% |
| |
Total impurity≤23.0% |
| Potency(Moisture basis) |
------- |
| Potency (Dried basis) |
≥19000IU/mg |
Colistin sulfate is a sulfate salt of the mixture of polymixins which areclosely related antimicrobial polypeptides produced by Bacillus polymyxa var. colistinus. Polymyxin E1 and polymyxin E2 are major active components in commercial colistin sulfate, and the others (polymyxin E3, E1-I, E1-7MOA) are less active.
Characteristics
ØNomenclature
•International Nonproprietary Name (INN):Colistin sulfate
•Compendial name: Colistin sulfate
•Synonym: Polymyxin E sulfate
•Molecular formula: [C53H100N16O13]·xH2SO4
•Relative molecular mass: 1155-1170
•Company's code: LNE
•Chemical Abstracts Service (CAS) registry number: 1264-72-8
ØPhysico-chemical properties
•White or almost white, hygroscopic powder
•Freely soluble in water, practically insoluble in acetone and in ethanol.
•Non-sterilegrade
•Type of particle:
1. Product of fine particle [100% pass through 20 mesh sieve (850μm)]
2. Product of compacted particle[ ≥ 95% pass through 1400μm, and ≤40% pass through 355μm]
ØBiological properties
•High effective against Gram-negative bacteria but little activity against Gram-positive bacteria
Compliance with Pharmacopoeia
We regularly supplies two different types of colistinsulfateto satisfy customers' needs. Those areproduct of fine powdered particle and compacted particle, respectively. The compacted type of colistin sulfate produced by dry granulation without addition of any excipient, has several advantages such as good flowability, excellent solubility, and less dust.
ØColistin sulfateconforms to EU Pharmacopoeia 9.0 (Furnished withCEP No. R0-CEP 2013-257-Rev 01)
•Microbiological assay (dry basis): ≥19,000 IU/mg
•Limit of polymyxin E3: ≤10.0%
•Limit of polymyxin E1-I: ≤10.0%
•Limit of polymyxin E1-7MOA: ≤10.0%
•Sum of polymyxin E1, E2, E3, E1-Iand E1-7MOA: ≥ 77.0%
ØColistin sulfateconforms to EU Pharmacopoeia 9.0(Continued) (Furnished withCEP No. R0-CEP 2013-257-Rev 01)
•Polymyxin B2:≤2.0%
•Impurity 1 (RRT0.18):≤1.5%
•Impurity 2 (RRT0.23):≤2.0%
•Impurity 3 (RRT0.34):≤1.5%
•Impurity 4 (RRT0.37):≤1.5%
•Impurity 5 (RRT0.42):≤2.0%
•Impurity 6 (RRT0.93):≤2.0%
•Impurity 7 (RRT0.27):≤1.0%
•Any unspecified impurity:≤1.0%
•Total of impurity:≤23.0%
Indication and Application
Colistin sulfate is mainly used for treatment of animals infected by Gram-negative bacteria like E. coli, pseudomonasand Acinetobacter spp.It is usually administered orally in feed, drinking water or milk replacer diet. Colistin sulfate is also used as a starting material to synthesize a human use drug of colistimethate sodium.
Regulatory Compliances
Following documents and certificates are available as requested;
•Certificate of Suitability to the monographs of the European Pharmacopoeia(CEP)
•EU Drug Master File (DMF) with full impurity profile complies with EMA requirements
•EU GMP (Germany) Certificate
•Australia GMP Compliance Letter
•Chinese MOA GMP certificate
•Letter of Access
Availability
Both compacted non-sterile colistin sulfateand fine powdered non-sterile colistin sulfatecompliedwith EP 9.0(≥19,000 IU/mg) are available. Each product has three different package sizesof 2 kg, 5 kg, and 20 kg.
Storage: To be stored away from light in a cool and dry place
Remards: Colistin Sulphate 1Ug=30Units(potency)
Precautions: 1) The drug should be prohibited during layering period.
2) Do not use in combination with aureomycin, terramycin, bacitracin and olaquindox.
3) When used for acute enteritis, rate of use shall be twice the maximum limit of the dose above.
4) Dispose of in accordance with corresponding environmental regulations.
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To get more information, just feel free to contact with us. Thanks.
Mr. Liu
Qingdao Fraken International Trading Co., Ltd
Address: RM1005 post mansion yan'an three road, Qingdao, China
Web: http://fraken.en.made-in-china.com/
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