GPAT case studies

GPAT · Put your knowledge to work in context.

The Graduate Pharmacy Aptitude Test (GPAT) is a national-level entrance examination in India for admission to postgraduate pharmacy programmes and for pharmacy-related fellowships. It is aimed at candidates who hold or are completing a Bachelor of Pharmacy degree and want to move into an M.Pharm, Pharm.D (post-baccalaureate) or research pathway. The GPAT case studies are 5 cases and about 4,455 words.

Scaling a hygroscopic, thermolabile tablet from 30 kg to 300 kg

A 300 kg commercial batch of immediate-release tablets contains 45% w/w of a thermolabile, hygroscopic API (melting point about 68 °C, freely water-soluble, hydrolysis-limited t90 of 18 months at 30 °C/65% RH against a 24-month specification). The formula is API 45%, microcrystalline cellulose 40%, croscarmellose sodium 3%, colloidal silicon dioxide 0.5%, magnesium stearate 1%, lactose to 100%.

968 words, about 5 min 2

Atropine endpoints and intermediate syndrome after chlorpyrifos poisoning

A 42-year-old male farm worker is brought to the emergency department 90 minutes after his sleeve soaked with a concentrated chlorpyrifos formulation while spraying without protective equipment. He has copious salivation and bronchorrhea, pinpoint pupils, generalised fasciculations, generalised weakness and confusion.

846 words, about 4 min 3

Marker shortfall and adulteration signals in a '5% withanolides' ashwagandha capsule

A 500 mg hard-shell capsule marketed as 'Ashwagandha root extract 5% withanolides' carries a label claim of 5% w/w total withanolides by HPLC. A contract laboratory reports: withanolide A 0.9% and withaferin A 1.1% (total 2.0% w/w); total ash 14.2%; acid-insoluble ash 3.8%; loss on drying 9.0%; lead 6.2 ppm; and an HPTLC fingerprint showing an intense band at Rf 0.62 that is absent from the authenticated Withania somnifera root reference, plus a weak band matching leaf.

850 words, about 4 min 4

System suitability failure and a growing degradate in a fixed-dose combination assay

An RP-HPLC assay for a fixed-dose combination tablet (drug A 500 mg, drug B 50 mg) uses a 250 × 4.6 mm, 5 µm C18 column, methanol : 0.02 M phosphate buffer pH 3.0 (55:45, v/v), 1.0 mL/min, 240 nm, 20 µL injection. On a new column lot the system suitability run gives resolution between A and B of 1.2 (limit not less than 2.0), tailing factor for B of 2.4 (limit not more than 2.0), %RSD of five replicate injections 0.8% (limit not more than 2.0%) and plate count 2,100 (limit not less than 2,000).

876 words, about 4 min 5

Six findings in one retail pharmacy inspection

An inspector visits a retail pharmacy in Pune and records: (i) 40 strips of a third-generation cephalosporin (Schedule H1) with no corresponding entry in the Schedule H1 register; (ii) the register exists but its oldest entry is 8 months old and 12 entries lack the prescriber's name and registration number; (iii) three packs of a Schedule X sedative are kept on the open dispensing shelf; (iv) the pharmacy's registration certificate expired 12 days ago and the renewal application was filed only on the day of inspection; (v) the registered pharmacist leaves at 6 pm and a trained 'compounder' has been dispensing after 6 pm for the past three weeks; (vi) expired tablets sit in a labelled bin in the back room but have not been destroyed or returned and remain in the sales area. The owner argues that the pharmacy is '99% compliant' and that the inspector cannot take action because the renewal has been filed.

915 words, about 5 min