지오사이언스  T :  031-375-6493  E-Mail : info@gosci.co.kr

Intended For Use In Pharmaceutical GMP Processes 

• 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.

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.

Package Sizes:

• 200L drums