Excipient
ICH-Q7 GMP Manufactured ProductMOPS, Free Acid, GMP Excipient Grade
Product Code: MOPS-3220 | Previously: MP3220
Intended Use Statement
MOPS is a zwitterionic buffer used as a running buffer for denaturing gel electrophoresis and as a buffering agent in many biological and biochemical applications. MOPS interferes with the Folin protein assay and partially decomposes when autoclaved in the presence of glucose. MOPS can be used as a Good’s buffer because it has low UV absorptivity, minimal reactivity, stable pH and is soluble in water.
Product Specifications
| ANALYSIS | SPECIFICATIONS | |||||||||
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White / Crystals | |||||||||
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99.5% min. | |||||||||
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0.005% max. | |||||||||
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None Detected None Detected None Detected |
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Passes Test | |||||||||
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0.1% maximum | |||||||||
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1.0% maximum | |||||||||
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3.0-4.5 | |||||||||
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2.5-4.5 | |||||||||
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7.0-7.5 |
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0.1% maximum | |||||||||
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Passes Test | |||||||||
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0.005% maximum | |||||||||
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5 ppm maximum 5 ppm maximum 5 ppm maximum 5 ppm maximum |
| 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. |
| List of C of As files |
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MP3220-002-0317.pdf |
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MP3220-001-0317.pdf |
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
- Residual Solvents
- Gluten Free
- Ingredient Declaration
- REACH
- Prop 65
- Stability Data Statement
- Supply Chain
- Imidazole
- TUPP
- Formaldehyde
- Slip Agent Statement
- Nitrosamine Statement
- Genotoxic Impurities
- Phthalate, Bisphenol, Dioxin
- Catalyst
- Test Methods
- IRGAFOS
- Stability Report
MOPS-3220
CAS #: 1132-61-2
Formula: C7H15NO4S
Sol. In H20 (g/L): 980
F.W.: 209.26 g/mol
pH @ 20°C: 3.0 - 4.5
Useful pH: 6.5 - 7.9
pKa @ 20˚C: 7.2
General Product Description:
- The Manufacturing of MOPS MOPS-3220 is performed at BioSpectra’s Stroudsburg, PA facility and is conducted in a dedicated processing area using only dedicated equipment.
- MOPS is a White Crystalline product.
- Molecular Formula: C7H15NO4S
- Molecular Weight: 209.26 g/mol.
- CAS Number: 1132-61-2.
- There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
- BioSpectra certifies that all MOPS MOPS-3220 manufactured at BioSpectra and its raw materials are not derived from
or come in contact with animal parts, products, and/or byproducts. - MOPS manufactured at BioSpectra and any raw materials used in the manufacture of MOPS at BioSpectra are not subject to genetic modification.
- Synonyms: 3-(N-Morpholino)propanesulfonic acid, 4-Morpholinepropanesulfonic acid.
GMP Compliance:
Bio Excipient Grade MOPS MP3220 is manufactured in
accordance with cGMP guidelines and is suitable to be used only
as the following: ICH Q7 Compliant cGMP Manufactured Excipient
for use in further Manufacturing. This Grade of MOPS is not
suitable to be used as an Active Pharmaceutical Ingredient, Drug
Product or household item.
Retest Date:
The recommended retest period for MOPS is two years from the
date of manufacture.
Storage and Shipping Conditions:
Ship and Store in ambient temperature.
Package Sizes:
10kg, 25kg and 50kg pails.
Additional Packaging Information
https://www.biospectra.us/technical/packaging