EMAIL THIS PAGE TO A FRIEND

The Canadian journal of hospital pharmacy

Stability of extemporaneously compounded dexamethasone in glass and plastic bottles and plastic syringes.


PMID 25214658

Abstract

Dexamethasone is widely used to treat rheumatic and endocrine disorders and chemotherapy-induced nausea and vomiting. A palatable, alcohol-free liquid formulation, with a suitable concentration to allow reasonable administration volume, is available only via extemporaneous compounding. To evaluate the stability of dexamethasone suspensions in commercially available vehicles (Oral Mix and Oral Mix SF) in various types of containers after storage at 25°C and 4°C for up to 91 days. Dexamethasone suspensions (1 mg/mL) were prepared in Oral Mix and Oral Mix SF and then transferred to amber glass and plastic prescription bottles and plastic oral syringes. Suspensions in all 3 types of containers were stored at 25°C; suspensions in glass and plastic bottles were also stored at 4°C. Samples were collected weekly from each container up to 28 days and then every 2 weeks up to 91 days. The samples were analyzed by a validated, stability-indicating high-performance liquid chromatography - ultraviolet detection method. A suspension was considered stable if it maintained at least 90% of its initial dexamethasone concentration. Changes in colour, taste, odour, precipitation (and ease of resuspension), and pH were used to assess physical compatibility. All suspensions maintained at least 96% of the original concentration for up to 91 days with storage at 25°C or at 4°C. No notable changes in colour, taste, odour, precipitation, or pH were observed over the 91-day period. Dexamethasone suspensions (1 mg/mL) in Oral Mix and Oral Mix SF, stored in amber glass or plastic bottles or plastic syringes at 25°C or in amber glass or plastic bottles at 4°C can be expected to remain stable for up to 91 days.

Related Materials

Product #

Image

Description

Molecular Formula

Add to Cart

45983
Acetonitrile, analytical standard
C2H3N
PHR1551
Acetonitrile, Pharmaceutical Secondary Standard; Certified Reference Material
C2H3N
00712
Acetonitrile solution, ~20% in H2O, for protein sequence analysis
C2H3N
516961
Ammonium formate, ≥99.995% trace metals basis
CH5NO2
09735
Ammonium formate, BioUltra, ≥99.0% (calc. based on dry substance, NT)
CH5NO2
70221
Ammonium formate, for mass spectrometry, ≥99.0%
CH5NO2
78314
Ammonium formate solution, BioUltra, 10 M in H2O
CH5NO2
714690
Ammonium formate solution, 10 mM in H2O, for HPLC
CH5NO2
D9184
Dexamethasone, meets USP testing specifications
C22H29FO5
D0700000
Dexamethasone, European Pharmacopoeia (EP) Reference Standard
C22H29FO5
1176007
Dexamethasone, United States Pharmacopeia (USP) Reference Standard
C22H29FO5
46165
Dexamethasone, VETRANAL, analytical standard
C22H29FO5
31375
Dexamethasone, tested according to Ph.Eur.
C22H29FO5
PHR1526
Dexamethasone, Pharmaceutical Secondary Standard; Certified Reference Material
C22H29FO5
Y0001593
Dexamethasone for peak identification, European Pharmacopoeia (EP) Reference Standard
C22H29FO5
Y0001177
Dexamethasone for system suitability, European Pharmacopoeia (EP) Reference Standard
C22H29FO5
82762
Methanol, analytical standard
CH4O
PHR1372
Methanol, Pharmaceutical Secondary Standard; Certified Reference Material
CH4O
1424109
Methyl alcohol, United States Pharmacopeia (USP) Reference Standard
CH4O
295663
Propylene, ≥99%
C3H6
PHR1320
Residual Solvent - Acetonitrile, Pharmaceutical Secondary Standard; Certified Reference Material
C2H3N
1601340
Residual Solvent Class 2 - Acetonitrile, United States Pharmacopeia (USP) Reference Standard
C2H3N