Excipient
ICH-Q7 GMP Manufactured ProductD-GALACTOSE
LBLE LEI, EP, BP, NF, GMP, Plant Derived
Low Bioburden, Low Endotoxin, Low Elemental Impurities, EP, BP, NF, GMP Manufactured, Excipient Grade Product
Product Code: GALP-3251 | Previously: GA3251
Intended for Use in Pharma Mfg. Requiring ICH-Q7 Excipient Grade Quality & Regulatory Compliance
D-Galactose, Plant Derived is intended for use upstream and downstream in biological drug manufacturing processes. For this purpose, BioSpectra has categorized our product as an excipient though one of the primary functions is to be used as a nutrient in mammalian cell culture media. Given the sensitivity of these cells in regard to growth, BioSpectra’s D-Galactose is manufactured to meet high purity specifications and low bioburden and endotoxin demands.
Product Specifications
|
NF COMPENDIA |
|||
|---|---|---|---|
|
ANALYSIS |
SPECIFICATIONS |
||
|
Passes Test | ||
|
Passes Test |
||
|
98.0% – 102.0% | ||
|
Barium |
Passes Test |
||
|
Conforms to Reference | ||
|
Passes Test | ||
|
Passes Test | ||
|
1Limit of Lead |
≤ 0.5 ppm |
||
|
Absent Absent Absent Absent 3≤ 100 CFU/g ≤ 100 CFU/g |
||
|
≤ 0.6% ≤ 0.6% ≤ 0.6% ≤ 0.6% ≤ 0.6% ≤ 0.6% ≤ 0.2% ≤ 1.0% |
||
|
≤ 0.1% |
||
|
+78.0º to +81.5º |
||
|
≤ 1.0% | ||
|
EP COMPENDIA |
|||
|---|---|---|---|
|
ANALYSIS |
SPECIFICATIONS |
||
|
Passes Test | ||
|
White to almost white, crystalline or finely granulated powder |
||
|
Passes Test | ||
|
398.0 – 102.0% | ||
|
Conforms to Reference | ||
|
Passes Test | ||
|
Passes Test | ||
|
≤ 100 CFU/g | ||
|
≤ 0.1 mg/mL | ||
|
≤ 1.0% ≤ 0.3% ≤ 2.0% |
||
|
≤ 0.1% | ||
|
≤ 1.0% | ||
| ADDITIONAL ANALYSES | |||
|---|---|---|---|
|
ANALYSIS |
SPECIFICATIONS |
||
|
≤ 2.5 EU/g | ||
|
≤ 0.1% |
||
|
≤ 400 ppb ≤ 10 ppb ≤ 50 ppb ≤ 50 ppb ≤ 25 ppb ≤ 200 ppb ≤ 25 ppb ≤ 50 ppb ≤ 50 ppb ≤ 50 ppb ≤ 50 ppb ≤ 200 ppb |
||
|
≤ 500 ppm | ||
|
≤ 5000 ppm | ||
|
≤ 100 ppm | ||
|
≤ 500 ppm | ||
1Alternate Validated Method
2Analyses are Harmonized
3Specification is more stringent than Compendia Monograph
| Key Compliance Attributes of BioSpectra Grades | Bio Excipient Grade ICH-Q7 Compliant Manufactured | ||
|---|---|---|---|
|
 |
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
| indicates an attribute or level of compliance which is granted or available based on the purchase of the product grade. |
| Bio Excipient 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. |
COAs and Tech Docs
- Printable Spec Sheet
- Product Inquiry
- Compliance
- C of As
- SDS
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- Melamine
- Residual Solvents
- Gluten Free
- Prop 65
- Stability Data Statement
- Supply Chain
- Imidazole
- TUPP
- Formaldehyde
- Slip Agent Statement
- Nitrosamine Statement
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
- Stability Report
- Nitrosamine Risk Assessment
- Elemental Impurity Assessment
- Label Copy
- Certificate of Origin
- Storage Statement
- Stability Indicating Report
- Stability Indicating Protocol
- Residual Solvents Test Methods
GALP-3251
CAS #: 59-23-4
Formula: C6H12O6
Sol. In H2O (g/L): 600
F.W.: 180.16 g/mol
pKa @ 20˚C: 12.4
General Product Description:
- The Manufacturing of D-Galactose, Plant Derived GALP-3251 is performed at BioSpectra’s Bangor, PA facility utilizing multiuse equipment.
D-Galactose, Plant Derived is a white to almost white crystalline powder - Molecular Formula: C6H12O6
- Molecular Weight: 180.16 g/mol
- CAS Number: 59-23-4
- BioSpectra certifies that all D-Galactose, Plant Derived GALP-3251 manufactured at BioSpectra and its raw materials are allergen free.
- BioSpectra certifies that all D-Galactose, Plant Derived GALP-3251 manufactured
at BioSpectra, and its raw materials, are not derived from or come in contact with animal parts, products, and/or byproducts. - D-Galactose, Plant Derived manufactured at BioSpectra and any raw materials used in the manufacture of D-Galactose, Plant Derived at BioSpectra are not subject to genetic modification.
- Synonyms: D-Galactopyranose
GMP Compliance:
Bio Excipient Grade D-Galactose, Plant Derived GALP-3251 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of D-Galactose, Plant Derived is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
Retest Date:
The recommended retest period for D-Galactose, Plant Derived is two years from the date of manufacture.
Storage and Shipping Conditions:
Keep container tightly closed and store in a clean, dry and well-ventilated area. Store in the original container.
Package Sizes:
10kg & 25kg pails and 50kg drum.
Additional Packaging Information
https://www.biospectra.us/technical/packaging