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Query : Storage conditions of dilutions for drugs:Digoxin ,Ketamine and Ketorolac

Digoxin – 25 degree Celcius, Protect from light. Ketamine – 20-25 degree celcius, protect from light Ketorolac – 20-25 degree celcius, Protect from light

by: Ms. Rohini S P

Ketamine

Ketamine hydrochloride for injection is a rapid-acting general anesthetic agent.

The more dilute solution was stable for 12 months when stored at 4°C, 25°C, or 40°C, whereas the more concentrated solution was stable for 30 days at 25°C. with sterile water for injection, packaging in glass vials, and storage at room temperature.

On the day of analysis, all of the vials were allowed to thaw for 2 h at room temperature. Each sample was further diluted by combining 20 μL of solution with 100 μL of internal standard (phenol, 0.3 mg/mL) and 880 μL of 25% acetonitrile solution. A previously validated high-performance liquid chromatography method3 was used to assay the samples in duplicate. The pH of the solutions was monitored with a calibrated pH meter. Colour and clarity were monitored by the naked eye, with the aid of white and black backgrounds.

After 182 days storage at room temperature, the concentration of all samples remained above 90% (mean 96.2%;). The pH increased only slightly, from 4.74 to 4.90. Neither colour nor clarity of the samples changed over time.

Stability of Ketamine Stored in Glass Vials at Room Temperature with Exposure to Light*

On the basis of these results, it can be concluded that ketamine hydrochloride for injection 50 mg/mL, diluted to 10 mg/mL with sterile water for injection and packaged in glass vials, may be regarded as chemically stable after storage for up to 182 days at room temperature with exposure to light.

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Reference

1. Stucki MC, Fleury-Souverain S, Sautter AM, Sadeghipour F, Bonnabry P. Development of ready-to-use ketamine hydrochloride syringes for safe use in post-operative pain. Eur J Hosp Pharm Sci. 2008;14(1):14–8.

2. Gupta VD. Stability of ketamine hydrochloride injection after reconstitution in water for injection and storage in 1-mL tuberculin polypropylene syringes for pediatric use. Int J Pharm Compound. 2002;6(4):316–7. [PubMed]

3. Donnelly RF. Physical compatibility and chemical stability of ketamine–morphine mixtures in polypropylene syringes. Can J Hosp Pharm. 2009;62(1):28–33. [PMC free article] [PubMed]

DIGOXIN INJECTION

STORAGE

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

KETOROLAC

STORAGE

Store at 20ºC to 25ºC (68ºF to 77ºF) Protect from light If the solution is colored or cloudy, or contains

particulate matter, do not use.

IA: Up to 24 hours if refrigerated Up to 4 hours at room temperature

by : Ms. Sahitya Kurapati

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