Product Category

LBLE Active Substance (API)

ICH-Q7 GMP Manufactured Active Drug Substance

CYTIDINE, LBLE, API Grade

Low Bioburden, Low Endotoxin, GMP Manufactured

Product Code: CYTD-2250 | Previously: CT2250

Intended For Use As An Active Pharmaceutical Ingredient


Cytidine is a glycosylated pyrimidine-analog containing cytosine attached to a ribose ring via a β-N1-glycosidic bond. It is one of the five standard nucleosides which make up nucleic acid. Cytidine is used as a nutrient, an intermediate in pharmaceutical preparations with other GMP pharmaceutical applications. Cytidine is intended to be used as an Active Pharmaceutical Ingredient in oral and parenteral drug formulations.

Product Specifications

  ANALYSIS SPECIFICATIONS

Ammonium

 

≤ 100 ppm

Appearance

 

White Crystalline Powder

Arsenicum

 

≤ 2 ppm

Assay (HPLC)

 

98 – 102%

Bacterial Endotoxins

≤ 0.5 EU/mg

Dried Substance

 

≥ 99.0%

Heavy Metals

 

≤ 10 ppm

Identification A (IR)

 

Positive

Identification B (HPLC)

 

Positive

Methanol

 ≤ 1000 ppm

Melting Point

 210 – 220°C
pH of solution (water, 5%)  6.8 – 7.8

Phosphates

≤ 1000 ppm

Purity (HPLC)

 ≥ 98%

Related Substances (HPLC)

Cytosine
Cytidine
Any Unknown Impurity
Total Impurities

≤ 0.5%
≤ 0.5%
≤ 0.1%
≤ 2.0%

Transmittance of Solution (water, 5%)

≥ 97.0%

Water Content (KF)

≤ 1.0%

Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Active Grade ICH Q7 Compliant Manufactured
Suitable for Research and Diagnostic  
Yes-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Validated Manufacturing Process  
Yes-image
US Manufactured at BioSpectra  
Yes-image
Customized Additional Specifications  
Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image
ICH-Q7 Qualified Utilities  
Yes-image
ICH-Q7 Compliant Manufactured  
Yes-image
Type II Drug Master File  
Yes-image
Suitable for use as Active Ingredient  
Yes-image

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Active Grade: Intended for use as ICH-Q7 Compliant Active Pharmaceutical Ingredient 
LBLE: LBLE applies when product specifications include requirements for Bioburden Testing (TAMC/TYMC and/or Endotoxin).
LBLE stands for Low Bioburden, Low Endotoxin non-sterile products suitable for further use in parenteral manufacturing and other sterile applications.

 

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formula-image
formula-image

CYTD-2250

CAS #: 65-46-3

Formula:

C9H13N3O5

pKa @ 25°C: 4.22, 12.5
Solubility in Water: Freely Soluble

F.W.: 243.2 g/mol

General Product Description:

  • The manufacturing of Bio Active Grade Cytidine, CYTD-2250 is performed at BioSpectra’s Bangor, PA facility and is conducted in a dedicated processing area using only dedicated equipment. Equipment used in the manufacturing of CYTD-2250 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.
  • Molecular Formula: C9H13N3O5
  • Molecular Weight: 243.2 g/mol
  • CAS #: 65-46-3
  • Cytidine is a white crystalline product.
  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
  • BioSpectra certifies that all Cytidine, CYTD-2250 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
  • Cytidine manufactured at BioSpectra and any raw materials used in the manufacture of Cytidine at BioSpectra are not subject to genetic modification.
  • Synonyms: Cytosine β-D-riboside, Cytosine-1-β-D- ribofuranoside

 



GMP Compliance:

Bio Active Grade Cytidine, CYTD-2250 is suitable for use as a nonSterile Active Pharmaceutical Ingredient manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Cytidine is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item.

Retest Date:

The recommended retest period for Cytidine is two years from the date of manufacture.

Storage and Shipping Conditions:

Store in a tightly closed container in a dry, well-ventilated place

Package Sizes:

10kg and 25kg pails.

Additional Packaging Information

https://www.biospectra.us/technical/packaging