GMP Manufactured Process Chemical
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.
CAS #: 7647-01-0 / 67-63-0
Formula: 6M HCl / 1 LC3H8O
Solubility: Miscible with water
pH @ 20°C: <2
Density: 0.909
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ANALYSIS |
SPECIFICATIONS |
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Clear, colorless to slightly yellowish fuming liquid | ||
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≥ 5.9N | ||
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Passes Test |
Printable Version
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.
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.
The recommended retest period for 6M HCl in IPA solution is two years from the date of manufacture.
Storage temperature should be kept under 55°F away from incompatible and combustible substances. Keep containers tightly closed.
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
200L drums
American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.