- Online only
100GC® Spiroplasma citri
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
Cat. no.: 104-9001
$463.00
Tax excluded
Categories:
Related products
Do you have questions...
... about using our products?Contact Technical Support
... about ordering our products?
Get Ordering Help
... or about our company?
Send General Inquiry
Resources
Validation Guide
Validation Guide for 100GC® Spiroplasma citri
Please use this form to request a validation guide.
All fields are required. Please use your business contact data.
Please provide your first name. Please provide your last name. The e-mail seems to be missing or incorrect. Please provide your company/institution. Send Validation Guide
Unfortunately an error orcurred and the Validation Guide has not been sent.
You can try again, if the problem presists please contact us at info@minerva-biolabs.com
Try again
You can try again, if the problem presists please contact us at info@minerva-biolabs.com
Try again
Validation Guide has been successfully sent.
close
close
Product Description
Mycoplasmas represent one of the greatest contamination risks in cell cultures and in biopharmaceutical production (e.g. ATMPs). The US Pharmacopoeia (USP) <63> requires a validated test method for the release of such products, capable of detecting both culturable and non-culturable mycoplasmas. Nucleic acid amplification techniques (NAT) have become the new gold standard, as they reliably detect both forms. The previously applied sensitivity limit of 10 CFU/ml was based on classical culture methods.
The new USP <77> will change the requirements: For PCR methods, a sensitivity limit of 100 genome copies/ml (GC/ml) is introduced. This PCR-appropriate unit is considered practical for PCR laboratories and has long been expected as a standard for determining the detection limit.
Our 100GC® Mycoplasma Standards are specifically designed to meet these new requirements. They are non-infectious and therefore safe to handle, titrated to 100 GC, and comply with the new regulatory guideline for NAT standards. The standards are lyophilized and ready to use after reconstitution. In addition, the standards can be used as an external positve control with defined concentration, fulfilling all new regulatory requirements.
Optionally, 10 CFU/ml standards remain available for comparability with classical culture methods.
Application-Specific Relevance
Spiroplasma citri belongs to the genus Spiroplasma and is phylogenetically distinct from classical mycoplasma species. It is particularly relevant for manufacturing processes involving insect or plant cell lines. The 100GC® Spiroplasma citri standard supports matrix-specific assessment of potential contamination risks in non-mammalian expression systems.
Specification
| Product category | 100GC® Mycoplasma Standards |
|---|---|
| Species | Spiroplasma citri |
| Sample type | Purified mycoplasma nucleic acids (DNA/RNA-containing) |
| NCTC code | 10164 |
| ATCC code | 27556 |
| Application | Mycoplasma detection |
| Use cases |
|
| Contents |
|
| Detection method |
|
| Compliance | EP 2.6.7 and USP <77> |
| Required equipment & consumables |
|
| Concentration after reconstitution |
100 GC/ml |
| 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. 104-2001: Mycoplasma orale
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. 104-1101: Mycoplasma salivarium