Buffer Solutions

What's Your Challenge?

Product development in IVD relies on the quality and performance of raw materials that constitute the basic components of any reagent/kit. Buffers constitute a major critical reagent and help stabilize the reaction for analyte detection. Buffer solutions from Sigma-Aldrich are characterized by the absence of DNase, RNase and Nickase and have undergone extensive validation.

Increase diagnostic assay performance and supply chain transparency with products intended for IVD application use.

Sigma-Aldrich Buffer Solutions Provide Peace of Mind with:

  • Expiration date
  • Documented supply chain transparency
  • Qualified Process and Testing
  • QA review and release of every lot
  • Change control
  • Quality/regulatory support documentation in a ready format
  • Suitable for use in an IVD application

Accelerated Stability Results (Simulated 24 months)

Cat. No. pH
Time Zero
pH 24
Months
Bioburden
Time Zero
Bioburden
24 Months
Appearance
Time Zero
Appearance 24
Months
Ultra Pure
Time Zero
Ultra Pure
24 Months
Protein
Time Zero
Protein
24 Months
SRE0033 8.32 8.35 0 CFU / mL 0 CFU / mL Clear,
colorless liquid
Clear,
colorless liquid
No DNAse, RNAse,
NickAse, Protease,
Phosphatase detected
No DNAse, RNAse,
NickAse, Protease,
Phosphatase detected
SRE0035 0 CFU / mL 0 CFU / mL Clear,
colorless liquid
Clear,
colorless liquid
No DNAse, RNAse,
NickAse, Protease,
Phosphatase detected
No DNAse, RNAse,
NickAse, Protease,
Phosphatase detected
SRE0031 7.53 7.53 0 CFU / mL 0 CFU / mL Clear,
colorless liquid
Clear,
colorless liquid
No DNAse, RNAse,
NickAse, Protease,
Phosphatase detected
No DNAse, RNAse,
NickAse, Protease,
Phosphatase detected
SRE0032 7.42 7.48 0 CFU / mL 0 CFU / mL Clear,
colorless liquid
Clear,
colorless liquid
No DNAse, RNAse,
NickAse, Protease,
Phosphatase detected
No DNAse, RNAse,
NickAse, Protease,
Phosphatase detected
SRE0034 9.53 9.48 Dry powder,
granular
Dry powder,
granular
No DNAse, RNAse,
NickAse, Protease,
Phosphatase detected
No DNAse, RNAse,
NickAse, Protease,
Phosphatase detected
SRE0036 7 7.02 0 CFU / mL 0 CFU / mL Clear, yellow
liquid
Clear, yellow
liquid
No DNAse, RNAse,
NickAse detected
No DNAse, RNAse,
NickAse detected
100 mg/
mL
100 mg/
mL

Sigma-Aldrich has performed various stability tests including pH, bioburden, appearance, and UltraPure using accelerated stability testing.

Performance and Stability Data Using Sigma-Aldrich's New IVD Buffers

Sigma-Aldrich conducted a performance study using our new IVD Buffers. Data reveals that Sigma-Aldrich's
IVD buffers are comparable to kit-included buffers.

Materials

     
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