L-Cystine | 0.5 g |
Sodium Chloride | 2.5 g |
Dextrose (C6H12O6·H2O) | 5.5/5.0 g |
Agar, granulated (moisture content not exceeding 15%) |
0.75 g |
Yeast Extract (water-soluble) | 5.0 g |
Pancreatic Digest of Casein | 15.0 g |
Sodium Thioglycollate | 0.5 g |
or Thioglycolic Acid | 0.3 mL |
Resazurin Sodium Solution (1 in 1000), freshly prepared |
1.0 mL |
Purified Water | 1000 mL |
Pancreatic Digest of Casein | 17.0 g |
Papaic Digest of Soybean Meal | 3.0 g |
Sodium Chloride | 5.0 g |
Dibasic Potassium Phosphate | 2.5 g |
Dextrose (C6H12O6·H2O) | 2.5/2.3 g |
Purified Water | 1000 mL |
Aerobic bacteria | ||
Staphylococcus aureus1 | ATCC 6538, CIP 4.83, NCTC 10788, NCIMB 9518 | |
Bacillus subtilis | ATCC 6633, CIP 52.62, NCIMB 8054 | |
Pseudomonas aeruginosa2 | ATCC 9027, NCIMB 8626, CIP 82.118 | |
Anaerobic bacterium | ||
Clostridium sporogenes3 | ATCC 19404, CIP 79.3, NCTC 532 or ATCC 11437 | |
Fungi | ||
Candida albicans | ATCC 10231, IP 48.72, NCPF 3179 | |
Aspergillus niger | ATCC 16404, IP 1431.83, IMI 149007 | |
1
An alternative to Staphylococcus aureus is Bacillus subtilis (ATCC 6633).
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2
An alternative microorganism is Micrococcus luteus (Kocuria rhizophila), ATCC 9341.
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3
An alternative to Clostridium sporogenes, when a nonspore-forming microorganism is desired, is Bacetroides vulgatus (ATCC 8482).
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[NOTESeed-lot culture maintenance techniques (seed-lot systems) are used so that the viable microorganisms used for inoculation are not more than five passages removed from the original master seed lot.] |
Quantity per Container | Minimum Quantity to be Used (unless otherwise justified and authorized) |
Liquids (other than anitbiotics) | |
Less than 1 mL | The whole contents of each container |
140 mL | Half the contents of each container, but not less than 1 mL |
Greater than 40 mL, and not greater than 100 mL | 20 mL |
Greater than 100 mL | 10% of the contents of the container, but not less than 20 mL |
Antibiotic liquids | 1 mL |
Other preparations soluble in water or in isopropyl myristate |
The whole contents of each container to provide not less than 200 mg |
Insoluble preparations, creams, and ointments to be suspended or emulsified |
Use the contents of each container to provide not less than 200 mg |
Solids | |
Less than 50 mg | The whole contents of each container |
50 mg or more, but less than 300 mg | Half the contents of each container, but not less than 50 mg |
300 mg5 g | 150 mg |
Greater than 5 g | 500 mg |
Devices | |
Catgut and other surgical sutures for veterinary use | 3 sections of a strand (each 30-cm long) |
Surgical dressing/cotton/gauze (in packages) | 100 mg per package |
Sutures and other individually packaged single-use material | The whole device |
Other medical devices | The whole device, cut into pieces or disassembled |
Number of Items in the Batch | Minimum Number of Items to be Tested for Each Medium (unless otherwise justified and authorized)* |
Parenteral preparations | |
Not more than 100 containers | 10% or 4 containers, whichever is the greater |
More than 100 but not more than 500 containers | 10 containers |
More than 500 containers | 2% or 20 containers, whichever is less |
For large-volume parenterals | 2% or 10 containers, whichever is less |
Antibiotic solids | |
Pharmacy bulk packages (<5 g) | 20 containers |
Pharmacy bulk packages (5 g) | 6 containers |
Bulks and blends | See Bulk solid products |
Ophthalmic and other noninjectable preparations | |
Not more than 200 containers | 5% or 2 containers, whichever is the greater |
More than 200 containers | 10 containers |
If the product is presented in the form of single-dose containers, apply the scheme shown above for preparations for parenteral use. |
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Devices | |
Catgut and other surgical sutures for veterinary use | 2% or 5 packages, whichever is the greater, up to a maximum total of 20 packages |
Not more than 100 articles | 10% or 4 articles, whichever is greater |
More than 100, but not more than 500 articles | 10 articles |
More than 500 articles | 2% or 20 articles, whichever is less |
Bulk solid products | |
Up to 4 containers | Each container |
More than 4 containers, but not more than 50 containers | 20% or 4 containers, whichever is greater |
More than 50 containers | 2% or 10 containers, whichever is greater |
*
If the contents of one container are enough to inoculate the two media, this column gives the number of containers needed for both the media together.
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