Product Category

GMP Solution

GMP Manufactured Process Chemical

6M HCl in IPA, GMP Grade

Product Code: IHCL-4101 | Previously: IH4101

Intended Use Statement


BioSpectra’s product “6M HCl in IPA” is a fully validated GMP compounded solution. 6M HCl in IPA is used in the manufacture of pharmaceuticals to obtain a hydrochloride salt.

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance and Color  
Clear, colorless to slightly yellowish fuming liquid
Assay (Acid titration)  
≥ 5.9N
Identification (Chloride)  
Passes Test
Printable Version
Key Compliance Attributes of BioSpectra Grades Bio Pharma Grade IPEC GMP Compliant Manufactured
Suitable for Research and Diagnostic  
Yes-image
Each Batch 100% Analyzed  
Yes-image
Management of Change  
Yes-image
Validated Analytical Methods  
Yes-image
Compendial Testing  
Yes-image
Trace Metals Analyzed  
Yes-image
Stability Testing Program  
Yes-image
BioSpectra Supply Chain Audit Trail  
Yes-image
Product Origin Statement  
Yes-image
Customer Quality Audits  
Yes-image
Validated Manufacturing Process  
Yes-image
US Manufactured at BioSpectra  
Yes-image
IPEC cGMP Compliant Manufactured  
Yes-image
Customized Additional Specifications Yes-image
Multi-Compendial Testing  
Yes-image
Low Bioburden Low Endotoxin (LBLE)  
Yes-image
Enzyme Tested  
Yes-image
Suitable for use as Excipient  
Yes-image
Microbial / Endotoxin Tested  
Yes-image
Manufactured in FDA Registered Facility  
Yes-image
Customized Manufacturing Schedule  
Yes-image
Custom Regulatory Packet  
Yes-image
Accelerated Stability  
Yes-image
Video Conference access to BioSpectra Sites  
Yes-image
Complete access to Product Traceability  
Yes-image
Access to Supply Chain Information  
Yes-image

Yes-imageindicates an attribute or level of compliance which is granted or available based on the purchase of the product grade.
Bio Pharma Grade: Intended for use as IPEC cGMP Compliant Chemical
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.

 

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General Product Description:

The manufacturing of Bio Pharma Grade 6M HCl in IPA, IHCL-4101 is performed at BioSpectra’s Bangor, PA facility and is manufactured using multi-use equipment. Equipment used in the manufacturing of IHCL-4101 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.

  • Molecular Formula: 6M HCl / 1 LC3H8O
  • Density: 0.909
  • CAS #: 7647-01-0 / 67-63-0
  • 6M HCl in IPA is a clear, colorless to slightly yellowish fuming liquid.
  • There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
  • BioSpectra certifies that all 6M HCl in IPA, IHCL-4101 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
  • 6M HCl in IPA manufactured at BioSpectra and any raw materials used in the manufacture of 6M HCl in IPA at BioSpectra are not subject to genetic modification.
  • Synonyms: Hydrogen Chloride in 2-Propanol Solution, Hydrochloric acid in 2-Propanol


GMP Compliance:

Bio Pharma Grade 6M HCl in IPA IHCL-4101 is suitable for use as a process chemical. It is manufactured in accordance with the IPEC-PQG Joint Good Manufacturing Practice Guide. This grade of 6M HCl in IPA is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

Retest Date:

The recommended retest period for 6M HCl in IPA solution is two years from the date of manufacture.

Storage and Shipping Conditions:

Storage temperature should be kept under 55°F away from incompatible and combustible substances. Keep containers tightly closed.

GHS Classification:

Pictograms  

Signal Word - Danger 

Hazard Statements
    H225 - Highly flammable liquid and vapor
    H290 - May be corrosive to metals
    H319 - Causes serious eye irritation
    H336 - May cause drowsiness or dizziness

Package Sizes:

200L drums

Additional Packaging Information

https://www.biospectra.us/technical/packaging