Storage stability

All types of povidone, with exception of povidone K 90, have very good storage stability in the pure form. Table 24 lists the minimum stabilities in the original sealed container at room temperature when these are stored and tested according to the requirements of the pharmacopoeias (see Section 2.2.1.2). Recently some povidone grades are commercialized with hermetically sealed aluminium-PE inliners under nitrogen and vacuum to increase the long term stability. This is mainly of interest for povidone K 90. 

The lower stability of povidone K 90, compared with the other grades, is due to a slow decrease in the K-value. All the other parameters change just as little over a period of years, as those of other grades. If povidone K 90 is stored under cool conditions or if the original packaging never was opened the K-value decreases much less und the peroxides level remains much lower. 

In the presence of atmospheric oxygen, the peroxide content of all the types of povidone grades slowly increases, but remains below the value of 400 ppm, calculated as H202, specified in Ph.Eur., within the storage periods given in Table 24. 

The influence on the povidone powders of sterilization with gamma radiation was determined on a batch of Kollidon 17 PF. Table 25 shows that this form of sterilization does not change either the molecular weight or the molecular weight distribution. 

Because of the good stability of povidone on its own, its stability in solid dosage forms is usually also good. 

---

Storage disorders Storage hardening Storage media Storage stability Storage tankage... 

Rate of hydrolysis Stability Storage stability Decomposition... 

Stability Study Type Stability Storage Conditions Minimum Time Period Covered by Data at Submission (months) ... 

Sensitivity to Impact — See Impact Sensitivity Sensitivity to Sympathetic Detonation From 60% Dynamite — more sensitive than TNT (Ref 13) Stability in Storage. See Surveillance Surveillance. Storage for 6 months in a closed tube at 65° caused no decrease in stability. Storage for 30 days at 100° produced no red fumes of nitrogen dioxide (Ref 12)... 

A change from previously approved stability storage conditions to storage conditions recommended in International Conference on Harmoni-sation (tCH) guidances. 

TABLE 6.20 Butorphanol degradants from long-term stability storage of an aqueous formulation identified with LC/MS and template structure analysis... 

Cloned, pH stability, Temperature stability [°C], Organic solvent stability, Oxidation stability, General stability, Storage stability, Renatured, and Links to other databases and references. 

Kerwin, B. A., Heller, M. C., Levin, S. H., and Randolph, T. W. (1998), Effects of Tween 80 and sucrose on the acute short term stability and long term stability storage at -20 degrees of a recombinant hemoglobin,/. Pharm. Sci., 87,1062-1068. 

In 1-octanol, the magnitude of the stabilized storage modulus value G (ea. 104 Pa for % 0.01) is much larger than the loss modulus G" (ca. 1500 Pa), as expected for a gel (Fig. 8). Comparison of the magnitude of the elasticity of the gel network with that of other systems suggests that the interaction zones are permanent and highly ordered (crystalline) inicrodomains at a constant temperature... 

Each chemical entity identified as a drug product leachable under appropriate stability storage conditions was also identified as an extractable from one or more container closure system component (i.e., qualitative correlation). 

---