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100CFU® Mycoplasma Standards
(EP 2.6.7 (12.2) compliant
If you are looking for the Original Mycoplasma 100CFU™ Sensitivity Standards Product codes 103-XXX
click here
Mycoplasma contamination represents one of the major 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 r
eliably detecting both cultivable and
non-cultivable mycoplasma.
100CFU® Mycoplasma Standards were specifically developed to meet
these regulatory requirements and are particularly intended for use as
an External Positive Control (EPC). 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 robust
assessment of assay performance under routine conditions and to support
Limit of Detection (LOD) determination.
Application-Specific Relevance
Mycoplasma arginini is closely associated with bovine
contamination sources and is particularly considered in processes
involving bovine-derived raw materials such as serum. The 100CFU®
Mycoplasma arginini standard is therefore especially relevant for
manufacturing settings using bovine materials and supports
matrix-specific assessment of potential contamination risks.
Specification
| Product category |
100CFU® 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
- External positive control
- Assay performance evaluation
- QC release and routine testing
|
| Regulatory compliance |
EP 2.6.7 (12.2), USP <77>, JP 18 G3 |
| Contents |
- 3 vials ≤100 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 |
≤100 CFU/ml |
| Storage |
2-8 °C |
| Shipping |
Ambient temperature |
| Shelf life |
See package labeling |
Downloads
More Available Species
Cat. No. 106-2001: Mycoplasma orale
Cat. No. 106-3001: Mycoplasma gallisepticum
Cat. No. 106-4001: Mycoplasma pneumoniae
Cat. No. 106-5001: Mycoplasma synoviae
Cat. No. 106-6001: Mycoplasma fermentans
Cat. No. 106-7001: Mycoplasma hyorhinis
Cat. No. 106-8001: Acholeplasma laidlawii
Cat. No. 106-9001: Spiroplasma citri
Cat. No. 106-1101: Mycoplasma salivarium
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