Sucrose, Beet Derived, LBLE

BIO EXCIPIENT GRADE | SB3250

C of As and Tech Docs

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): 2120

F.W.: 342.30 g/mol

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.


Meets or Exceeds EP/BP, JP and NF specifications.

 

ANALYSIS

SPECIFICATIONS

Appearance  
White to off-white Crystalline Powder or Crystals
Appearance of Solution (NF)  
Passes Test
Appearance of Solution (EP)  
Clear
Color Value  
≤ 45
Conductivity ≤ 35 μS/cm
Dextrins  
Passes Test
Elemental Impurities Antimony
Arsenic
Cadmium
Cobalt
Copper
Lead
Lithium
Mercury
Nickel
Vanadium
≤ 0.75 ppm
≤ 0.13 ppm
≤ 0.017 ppm
≤ 0.042 ppm
≤ 2.5 ppm
≤ 0.042 ppm
≤ 2.1 ppm
≤ 0.025 ppm
≤ 0.17 ppm
≤ 0.083 ppm
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
Residual Ethanol  
≤ 600 ppm
Residual Methanol  
≤ 300 ppm
Specific Rotation at 20oC  
+66.3° to +67.0°
Sulfites  
≤ 10 ppm

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
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Review the below Intended End Use Statements for each Grade and Choose the Product Grade that is most applicable to your use.


a.) Bio Pharma Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: IPEC Compliant GMP Manufactured Chemical, for use in further Manufacturing or as a Reagent for Laboratory and Research. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.


b.) Bio Excipient Grade INTENDED USE: Material represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Excipient for use in further Manufacturing. The material represented by this Grade is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.


c.) O Bio Active Grade INTENDED USE: Material Represented by this Grade is suitable to be used only as the following: ICH Q7 Compliant cGMP Manufactured Active Pharmaceutical Ingredient for use in further Manufacturing or use in Drug Product Manufacturing. The material represented by this Grade is not suitable to be used as a Sterile or Injectable Active Pharmaceutical Ingredient, Drug Product or Household Item. (This statement will change depending on the status of your Drug Application in accordance with 21 CFR §201.122)

General Product Description:

  • The manufacturing of Sucrose SB3250 is performed at BioSpectra’s Bangor, PA facility and utilizes multiuse equipment. Equipment used in the manufacturing of Sucrose Bio Excipient grade is cleaned in accordance with BioSpectra’s Process Cleaning Validation Master Plan.
  • 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 as an ICH Q7 Compliant cGMP Manufactured Excipient. This Grade of Sucrose is suitable for use in Sterile or Injectable applications where terminal sterilization is required. It is not intended for use as an 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.