GMP Solution
ICH-Q7 GMP Manufactured ProductSodium Chloride 5M Soln.
GMP, LBLE, Excipient Grade
Made with WFI & Multicompendial NaCl xtl, Sterile Filtered into Sterile Single Use Pkg.
Product Code: NACL-3150 | Previously: NC3150
Intended For Use as a GMP Solution For Critical Process and Excipient Applications
BioSpectra’s 5M GMP NaCl is manufactured under ISO Class 6 environmental controls to meet stringent quality attributes for in-process and downstream use in BioPharma applications. The product is made with multicompendial salt and water for injection. It is sterile filtered into custom, sterile, single use biocompatible packaging. This product and process is fully validated under FDA guidelines.
Product Specifications
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ANALYSIS |
SPECIFICATIONS |
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Clear Colorless Solution | ||
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4.9-5.1M | ||
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≤ 2.5 EU/mL | ||
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Meets Requirements Meets Requirements |
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≤ 50 CFU/g ≤ 150 CFU/g |
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≤ 2 ppm ≤ 2 ppm ≤ 2 ppm ≤ 2 ppm |
| Key Compliance Attributes of BioSpectra Grades | Bio Excipient 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 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
- Elemental Impurities
- Regulatory Packet
- Process Flow Diagram
- GMP Statement
- Animal Origin Statement
- BSE/TSE
- Allergen
- Mycotoxin/Aflatoxin
- GMO Statement
- Melamine
- Gluten Free
- Ingredient Declaration
- Prop 65
- Stability Data Statement
- Supply Chain
- Imidazole
- TUPP Report - Stroudsburg
- Formaldehyde
- Slip Agent Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Test Methods
- IRGAFOS
- Degradation and Impurity
- Nitrosamine Risk Assessment
- Elemental Impurity Assessment
- Label Copy
- Certificate of Origin
NACL-3150
CAS #: 7647-14-5
Formula: NaCl
Sol. In H2O (g/L): 360 g/L (25 ºC)
F.W.: 58.44 g/mol
General Product Description:
The manufacturing of Bio Excipient Grade Sodium Chloride 5M,
NACL-3150 is performed at BioSpectra’s Bangor, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
- Molecular Formula: NaCl
- Molecular Weight: 58.44 g/mol.
- CAS#: 7647-14-5
- Sodium Chloride 5M is a clear colorless solution.
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all Sodium Chloride 5M, NACL-3150 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
- Sodium Chloride 5M solution manufactured at BioSpectra and any raw materials used in the manufacture of Sodium Chloride 5M at BioSpectra are not subject to genetic modification.
- Manufactured with WFI water.
GMP Compliance:
Bio Excipient Grade Sodium Chloride 5M NACL-3150 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of Sodium Chloride 5M Solution is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.
Storage and Shipping Conditions:
Ship and Store in ambient temperature.
Package Sizes:
1025L in a BPC bag placed in a tote
Additional Packaging Information
https://www.biospectra.us/technical/packaging