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100GC® Mycoplasma orale
100GC® Mycoplasma Standards are purified nucleic acid standards designed as reference material for product-specific validation of PCR-based mycoplasma testing methods.
- Compliant with EP 2.6.7 (12.2) and USP <77>
- Defined concentration of <100 GC/ml
- Suitable for product-specific validation and for use as EPC/EIC
- Optimized for PCR-based applications
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Product Description
Validated mycoplasma testing is required for biopharmaceutical products, cell culture-derived products, and ATMPs according to EP 2.6.7, USP <77>, and JP 18 G3.
With the revision of EP 2.6.7, Edition 12.2, and the introduction of USP <77>, NAT-based mycoplasma testing is supported by the unit genome copies (GC). In addition to the established limit of ≤ 10 CFU/mL, a sensitivity requirement of < 100 GC/mL has been introduced for PCR-based mycoplasma detection.
100GC® Mycoplasma Standards are purified mycoplasma nucleic acid standards designed to meet these regulatory requirements. They are suitable for LOD determination, product-specific validation (“test for inhibitory substances” and “method suitability testing”), and use as external positive control (EPC)/extraction inhibition control (EIC) in NAT-based mycoplasma testing.
Manufactured in accordance with EP 2.6.7 (12.2), the standards support validated mycoplasma detection workflows according to EP 2.6.7, USP <77>, and JP 18 G3.
The exact GC value is provided in the Certificate of Analysis (CoA).
Application-Specific Relevance
Mycoplasma orale is among the most frequently reported contaminants of human cell lines and is closely associated with human cell culture systems. The 100GC® Mycoplasma orale standard is therefore particularly relevant for manufacturing processes involving human cell substrates and supports matrix-specific assessment of potential contamination risks in human cell culture and vaccine production processes.
Specification
ApplicationMycoplasma detection
| Product category | 100GC® Mycoplasma Standards |
|---|---|
| Species | Mycoplasma orale (Metamycoplasma orale) |
| Sample type | Purified mycoplasma nucleic acids (DNA/RNA-containing) |
| NCTC code | 10112 |
| ATCC code | 23714 |
| Application | Mycoplasma detection |
| Application areas |
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| Contents |
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| Detection method |
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| Compliance | EP 2.6.7 and USP <77> |
| Required equipment & consumables |
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| Concentration | <100 GC/ml (exact value provided in CoA) |
| Storage | 2-8 °C |
| Shipping | Ambient temperature |
| Shelf life | See expiration date on package |
More Available Species
Cat. No. 104-1001: Mycoplasma arginini
Cat. No. 104-3001: Mycoplasma gallisepticum
Cat. No. 104-4001: Mycoplasma pneumoniae
Cat. No. 104-5001: Mycoplasma synoviae
Cat. No. 104-6001: Mycoplasma fermentans
Cat. No. 104-7001: Mycoplasma hyorhinis
Cat. No. 104-8001: Acholeplasma laidlawii
Cat. No. 104-9001: Spiroplasma citri
Cat. No. 104-1101: Mycoplasma salivarium
