Product Category

GMP Buffer

GMP Manufactured Process Chemical

MOPS, Free Acid, USP, GMP Grade

Product Code: MOPS-4220 | Previously: MP4220

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
  250 nm
Absorbance (0.1M) 260 nm
  280 nm
0.020 a.u. maximum
0.020 a.u. maximum.
0.020 a.u. maximum
Appearance and Color  
White / Crystals
Assay  
99.5% min.
Chloride  
0.005% max.
Enzymes

DNase

RNase

Protease

None Detected
None Detected
None Detected
Identification (IR)  
Passes Test
Karl Fischer Water  
0.1% max.
Loss on Drying  
1.0% max.
pH (1% solution)  
3.0-4.5

pH (2.5M)

 
2.5-4.5
pKa  

7.0-7.5

Residue on Ignition  
0.1% max.
Solubility (5%)  
Passes Test
Sulfate  
0.005% max.
Trace Metals Arsenic (As)
Copper (Cu)
Iron (Fe)
Lead (Pb)
5 ppm max.
5 ppm max.
5 ppm max.
5 ppm max.
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 MOPS MOPS-4220 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-4220 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 Pharma Grade MOPS, Free Acid MOPS-4220 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 MOPS, Free Acid is not suitable to be used as an Active Pharmaceutical Ingredient, Drug, 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