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Product Description

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, E_1-I, E_1-7MOA) are less active.  

Characteristics

Ø        Nomenclature

•           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

Ø        Physico-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]

Ø        Biological properties

•           High effective against Gram-negative bacteria but little activity against

Gram-positive bacteria

Compliance with Pharmacopoeia

Lifecome Biochemistry Co. 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.

Ø        Colistin 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 E_1-I: ≤10.0%

• ;          Limit of polymyxin E_1-7MOA: ≤10.0%

•         ;  Sum of polymyxin E₁, E₂, E₃, E_1-Iand E_1-7MOA: ≥ 77.0%

Ø        Colistin 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

•           AustraliaGMP 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.

Other Information

Ø        Self-life is 24months from the date of manufacture

Ø        Protect contents from humidity after opening, store in a dry and cool place