Name: Colistin Sulfate

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, E1-I, E1-7MOA) 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 E1-I: ≤10.0%

•           Limit of polymyxin E1-7MOA: ≤10.0%

•           Sum of polymyxin E1, E2, E3, E1-Iand E1-7MOA: ≥ 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 ofcolistimethate 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

FAQ

Q1:Why do you choose Greenbo Biochem as your partner?

A1.High quality can be guaranteed. Greenbo Biochem since 1990 are reputed API manufacturer and are Certified by ISO,GMP,FDA and have CEP/COS certification.Free sample can be arranged before shipment and SGS,BV and other third party inspection company are accepted before loading.For regular customers, we accept L/C payment term. If there is any quality problem after goods arrive. Greenbo Biochem will do fully payment refund. 

A2. Best price can be guaranteed. As Greenbo Biochem are integrated pharmaceuticals and chemicals producer

the production cost can be controlled and price will be definitely more competitive than China trading companies.

A3.Professional engineer from Greenbo Biochem will give professional usage guide and services after sales.

Q2: Can i get some samples?
A: Yes, we can supply the free sample, but the shipping cost be paid by our customers.
Q3: How to start orders or make payments?
A: Proforma invoice will be sent first after confirmation of order, enclosed our bank information. Payment by T/T, Western Union or Paypal or Escrow(Alibaba).
Q4: How to confirm the Product Quality before placing orders?
A:You can get free samples for some products,you only need to pay the shipping cost or arrange a courier to us and take the samples. You can send us your product specifications and requests,we will manufacture the products according to your requests.
Q5:What’s your MOQ?
A:Our MOQ is 1kg. But usually we accept less quantity such as 100g on the condition that sample charge is 100% paid.
Q6: How about delivery lead time?
A:Delivery lead time: About 3-5 days after payment confirmed. (Chinese holiday not included)