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10CFU® Mycoplasma Standards EP 2.6.7(12.2) compliant
If you are looking for the Original Mycoplasma 100CFU™ Sensitivity Standards Product codes 102-XXX
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Product Description
Mycoplasma contamination represents one of
the most critical risks in cell culture systems and biopharmaceutical
manufacturing, including ATMPs. The European Pharmacopoeia (EP) 2.6.7,
the United States Pharmacopeia (USP) <77>, and the Japanese
Pharmacopoeia (JP) 18 G3 require validated test methods capable of
detecting both cultivable and non-cultivable mycoplasma.
10CFU® Mycoplasma Standards were specifically developed to meet these
regulatory requirements. Manufactured in accordance with EP 2.6.7
(edition 12.2), the standards are non-infectious and safe to handle.
After reconstitution, defined quantities of the standard are spiked into
the respective product or sample matrix to enable Limit of Detection
(LOD) determination and use as an External Positive Control (EPC) with a
defined concentration.
Application-Specific Relevance
Mycoplasma arginini is a well-recognized representative of
bovine contamination sources and is particularly associated with
processes involving bovine-derived materials, such as serum. The 10CFU®
Mycoplasma arginini standard is therefore especially suitable for
matrix-specific, risk-based validation of NAT-based mycoplasma testing
in manufacturing processes with bovine origin.
Specification
| Product category |
10CFU® Mycoplasma Standards |
| Species |
Mycoplasma arginini |
| Sample type |
Inactivated mycoplasma particles (DNA/RNA-containing) |
| NCTC code |
10129 |
| ATCC code |
23838 |
| Application |
NAT-based mycoplasma testing |
| Application areas |
- Method validation
- Test for Inhibitory Substances (EP 2.6.7)
- Method Suitability Test (USP <77>)
- External positive control
- QC release and routine testing
|
| Regulatory compliance |
EP 2.6.7 (12.2), USP <77>, JP 18 G3 |
| Contents |
- 3 vials ≤10 CFU (lyophilized)
- 1 vial PCR-grade water
|
| Detection method |
- PCR
- real-time PCR (qPCR)
- digital PCR (dPCR/ddPCR™)
|
Required equipment
& consumables |
- PCR reaction tubes
- Centrifuge for 1.5 ml PCR reaction tubes
- Pipettes
- Mycoplasma detection kit
|
| Concentration |
≤10 CFU/ml |
| Storage |
2-8 °C |
| Shipping |
Ambient temperature |
| Shelf life |
See package labeling |
Downloads
More Available Species
Cat. No. 105-2001: Mycoplasma orale
Cat. No. 105-3001: Mycoplasma gallisepticum
Cat. No. 105-4001: Mycoplasma pneumoniae
Cat. No. 105-5001: Mycoplasma synoviae
Cat. No. 105-6001: Mycoplasma fermentans
Cat. No. 105-7001: Mycoplasma hyorhinis
Cat. No. 105-8001: Acholeplasma laidlawii
Cat. No. 105-9001: Spiroplasma citri
Cat. No. 105-1101: Mycoplasma salivarium
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