Pilocarpine Nitrate Ophthalmic Solution
» Pilocarpine Nitrate Ophthalmic Solution is a sterile, buffered, aqueous solution of Pilocarpine Nitrate. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C11H16N2O2·HNO3. It may contain suitable antimicrobial agents and stabilizers, and suitable additives to increase its viscosity.
Packaging and storage—
Preserve in tight, light-resistant containers.
Identification—
A:
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation obtained as directed in the Assay.
Sterility 
71
:
meets the requirements.
71:
meets the requirements.
pH 791:
between 4.0 and 5.5.
791:
between 4.0 and 5.5.
Assay—
Proceed with Ophthalmic Solution as directed in the Assay under Pilocarpine Hydrochloride Ophthalmic Solution, except to read pilocarpine nitrate instead of pilocarpine hydrochloride throughout and to calculate the quantity, in mg, of C11H16N2O2·HNO3 in each mL of the Ophthalmic Solution taken by the formula given therein.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
Chromatographic Column—
| Topic/Question | Contact | Expert Committee |
| Monograph | Feiwen Mao, M.S.
Scientist 1-301-816-8320 |
(MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
|
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 3307
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.