6N HCl in IPA, GMP Solution

BIO PHARMA GRADE | IH4101 | CAS# 7647-01-0 / 67-63-0

C of As and Tech Docs

INTENDED FOR USE IN PHARMACEUTICAL GMP PROCESSES

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BIO PHARMA GRADE | IH4101

CAS #: 7647-01-0 / 67-63-0

Molecular Formula:

HCl / C3H8O

Solubility in Water (g/L): Miscible with water

F.W.: 36.46 / 60.10 g/mol.

pH @ 20°C: Less than 2

BioSpectra’s product “6N HCl in IPA” is a fully validated GMP compounded solution for use in critical pharmaceutical drug manufacturing processes.


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

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
Each Batch 100% Analyzed  
Yes
Management of Change  
Yes
Validated Analytical Methods  
Yes
Compendial Testing  
Yes
Trace Metals Analyzed  
Yes
Stability Testing Program  
Yes
BioSpectra Supply Chain Audit Trail  
Yes
Product Origin Statement  
Yes
Customer Quality Audits  
Yes
Validated Manufacturing Process  
Yes
US Manufactured at BioSpectra  
Yes
IPEC cGMP Compliant Manufactured  
Yes
Customized Additional Specifications  
Yes
Multi-Compendial Testing  
Available
Enzyme Tested  
Available
Suitable for use as Excipient  
Available
Microbial / Endotoxin Tested  
Available
Manufactured in FDA Registered Facility  
Yes
Customized Manufacturing Schedule  
Available
Custom Regulatory Packet  
Available
Accelerated Stability  
Available
Type IV Drug Master File  
No
Video Conference access to BioSpectra Sites  
No
Complete access to Product Traceability  
No
Access to Supply Chain Information  
No
ICH Q7 Qualified Utilities  
No
ICH Q7 Compliant Manufactured  
No
Suitable for use as Active Ingredient  
No
Type II Drug Master File  
No
List of C of As files
IH4101-020-0420.pdf
IH4101-019-0320.pdf
IH4101-018-0320.pdf
IH4101-017-0220.pdf
IH4101-016-0120.pdf
IH4101-014-0819.pdf
IH4101-013-0819.pdf
IH4101-012-0619.pdf
IH4101-011-0519.pdf
IH4101-010-1018.pdf
IH4101-009-0318.pdf
IH4101-008-0318.pdf
IH4101-007-1217.pdf
IH4101-006-1217.pdf

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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 Bio Pharma Grade 6N HCl in IPA, IH4101 is performed at BioSpectra’s Bangor, PA facility and is manufactured using multi-use equipment. Equipment used in the manufacturing of IH4101 is cleaned in accordance with BioSpectra’s Cleaning Validation Plan.

  • Molecular Formula: HCl / C3H8O
  • Molecular Weight: 36.46 / 60.10 g/mol
  • CAS #: 7647-01-0 / 67-63-0
  • 6N 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 6N HCl in IPA, IH4101 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
  • 6N HCl in IPA manufactured at BioSpectra and any raw materials used in the manufacture of 6N 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 6N HCl in IPA, IH4101 is suitable for use as a GMP process chemical. It is manufactured in accordance with the IPEC Joint Good Manufacturing Practice Guide. This material is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, Drug Product or Household Item.

Expiration/Retest Date:

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

Storage and Shipping Conditions:

Store in a dry, well-ventilated area away from incompatible and combustible substances. Keep containers tightly closed.

Package Sizes:

200L drums