API
ICH-Q7 GMP ManufacturedLBLE Active Drug Substance
CYTIDINE, API, LBLE 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 | ||
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≤ 100 ppm |
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White Crystalline Powder |
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≤ 2 ppm |
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98 – 102% |
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Bacterial Endotoxins |
≤ 0.5 EU/mg |
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≥ 99.0% |
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≤ 10 ppm |
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Positive |
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Positive |
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Methanol |
≤ 1000 ppm | ||
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Melting Point |
210 – 220°C | ||
| pH of solution (water, 5%) | 6.8 – 7.8 | ||
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Phosphates |
≤ 1000 ppm |
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Purity (HPLC) |
≥ 98% | ||
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≤ 0.5% ≤ 0.5% ≤ 0.1% ≤ 2.0% |
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Transmittance of Solution (water, 5%) |
≥ 97.0% |
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Water Content (KF) |
≤ 1.0% |
| Key Compliance Attributes of BioSpectra Grades | Bio Active Grade ICH Q7 Compliant Manufactured | ||
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| indicates 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. |
| List of C of As files |
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| No files available right now. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
CYTD-2250
CAS #: 65-46-3
Formula:
pKa @ 25°C: 4.22, 12.5
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