PubMed · 4715099
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M A Bear. 1973. Proposal for a new single unit package.. https://pubmed.ncbi.nlm.nih.gov/4715099/
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The U.S. Pharmacopeia (USP) general monograph provides a standard for dissolution compliance with the requirements as stated in the individual USP monograph for a tablet or capsule dosage form. The acceptance rules recommended by USP have important roles in the quality control process. The USP rules and their modifications are often used as an industrial lot release sampling plan, where a lot is accepted when the tablets or capsules sampled are accepted as proof of compliance with the requirement. In this paper, the operating characteristics of the USP acceptance rules are reviewed and compared to a selected modification. The operating characteristics curves show that the USP acceptance rules are sensitive to the true mean dissolution and do not reject a lot or batch that has a large percentage of tablets that dissolve with less than the dissolution specification.
A simple and rapid method for the determination of etilefrine hydrochloride and ritodrine hydrochloride, either in pure form or in pharmaceutical formulations, is described. The method is based on the development of red product in presence of sodium nitrite and cobalt(II) salt in acid medium. The reaction is thought to proceed via preliminary nitrosation of the phenolic nucleus followed by formation of the chelate in presence of cobalt(II) salt. The highly colored chelates showed wavelengths of maximum absorption of 570 and 560 nm for etilefrine hydrochloride and ritodrine hydrochloride, respectively. The reaction product showed apparent molar absorptivities of 938 and 2930 L mol-1 cm-1 for etilefrine hydrochloride and ritodrine hydrochloride, respectively. A linear correlation was found between absorbance (at the lambda max) and concentration in ranges of 0.08-0.20 and 0.04-0.10 mg ml-1 for etilefrine hydrochloride and ritodrine hydrochloride, respectively. At the same time, the resulting colors were well developed within 25 min at boiling water bath temperature and were stable for more than 1 hr. Results of analysis of pure drugs and their dosage forms by the proposed method were in good agreement with either a reported derivative spectrophotometric procedure or the USP XXII method for etilefrine hydrochloride and ritodrine hydrochloride, respectively. The validity of the method was further confirmed using the standard addition method. The proposed method demonstrate high percentage of recovery with good accuracy and precision.
We report on 72 couples with previous failure of fertilization during several trials of conventional IVF. For the present study, a part of the aspirated oocytes was subjected to partial zona dissection before insemination, thereby achieving 7 pregnancies during 104 cycles. Normal in vitro insemination of the remaining zona-intact oocytes was unsuccessful again. Because microinsemination techniques, in contrast to routine IVF, are not yet offered by many clinics, we developed the following new concept: hormonal stimulation, sonographic control of follicular growth, aspiration of oocytes, and sperm preparation were performed at the usual place (Munich), whereas partial zona dissection and control IVF were accomplished in another laboratory (Ulm). To transport the gametes between these two institutes, we modified the previously reported intravaginal culture of inseminated oocytes by transferring oocytes and spermatozoa into separate plastic capsules. In our view, this procedure offers an opportunity for infertile couples living too far away from a microinsemination center to afford long daily journeys or even several overnight stays just for superovulation treatment. The fertilization and PRs in our study are comparable with those reported in the literature.