Sucrose, Beet Derived, LBLE

BIO EXCIPIENT GRADE | SB3250

INTENDED FOR USE AS AN EXCIPIENT

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BIO EXCIPIENT GRADE | SB3250

CAS #: 57-50-1

Molecular Formula:

C12H22O11

Solubility in Water (g/L): 2000

F.W.: 342.30 g/mol

pKa @ 25˚C: 12.6

Sucrose Excipient LBLE is a non-reducing disaccharide used as an excipient in biotherapeutic applications. Its primary purpose is to protect the protein drug substance both in the liquid and frozen state. It provides tonicity, stabilization, cryo-protection and lyo-protection. Sucrose can be used as a supplement for bacterial culture media and starting agent in alcohol fermentation. BioSpectra’s brand of LBLE Excipient Grade Sucrose is manufactured specifically for use as a parenteral drug ingredient. Additionally, Sucrose is used as an oral and injectable excipient in vaccines.


These are general specifications. BioSpectra will customize our products to meet your quality based requirements.

 

ANALYSIS

SPECIFICATIONS

Appearance  
White to off-white powder
Appearance of Solution (NF)  
Passes Test
Appearance of Solution (EP)  
Clear
Color Value  
≤ 45
Conductivity ≤ 35 μS/cm
Dextrins  
Passes Test
Elemental Impurities  
Complies
Endotoxins  
≤ 0.6 EU/g
Identification A (IR)  
Passes Test
Identification B  
Passes Test
Identification C  
Passes Test
Loss on Drying  
≤ 0.1 %
Microbial Content

Escherichia coli

Pseudomonas aeruginosa

Salmonella species

Staphylococcus aureus

TAMC

TYMC

Absent

Absent

Absent

Absent

≤ 20 CFU/g

≤ 10 CFU/g

Reducing Sugars  
Passes Test

Printable Version

Key Compliance Attributes of
BioSpectra Grades
Bio Excipient
Grade ICH Q7
Compliant
Manufactured
Suitable for Research and Diagnostic  
Yes
Each Batch 100% Analyzed  
Yes
Management of Change  
Yes
Validated Analytical Methods  
Yes
Compendial Testing  
Yes
Trace Metals Analyzed  
Yes
Two Year Stability  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Yes
Enzyme Tested  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Suitable for use as Excipient  
Yes
Microbial / Endotoxin Tested  
Yes
Manufactured in FDA Registered Facility  
Available
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available
Type IV Drug Master File  
Available
Video Conference access to BioSpectra Sites  
Available
Complete access to Product Traceability  
Available
Access to Supply Chain Information  
Yes
ICH Q7 Qualified Utilities  
Yes
ICH Q7 Compliant Manufactured  
Yes
List of C of As files
No files available right now.
 

Sucrose LBLE General Product Description:

  • The Manufacturing of Sucrose SB3250 is performed at BioSpectra’s Bangor, PA facility and is conducted in a dedicated processing area.
  • Sucrose is a White to off-white crystalline product
  • Molecular Formula: C12H22O11
  • Molecular Weight: 342.30 g/mol.
  • CAS Number: 57-50-1
  • BioSpectra certifies that all Sucrose SB3250 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products, and/or byproducts.
  • Sucrose manufactured at BioSpectra and any raw materials used in the manufacture of Sucrose at BioSpectra are not subject to genetic modification.
  • Synonyms: α-D-Glucopyranosyl β-D-fructofuranoside, α-D-Glc-(1→2)-β-D-Fru, D (+)-Saccharose, Sugar, β-D- Fructofuranosyl-α-D-glucopyranoside

GMP Compliance:

Bio Excipient Grade Sucrose SB3250 is manufactured in accordance with cGMP guidelines and is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured non-Sterile Excipient for use in further Manufacturing. This Grade of Sucrose is not suitable to be used as a Sterile or Injectable Excipient, Active Pharmaceutical Ingredient, Drug Product or Household Item

Expiration/Retest Date:

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

Storage and Shipping Conditions:

Expiration/Retest Date:

Ship and Store in ambient temperature. Keep container tightly closed in a dry and well-ventilated place.

Package Sizes:

10 kg and 25 kg pails and 50 kg drums.