Dosage forms and pharmacopeial standards in ISM MCQs With Answer

Introduction: Dosage forms and pharmacopeial standards in ISM MCQs With Answer is a focused quiz set designed for M.Pharm students specializing in Indian Systems of Medicine. This collection emphasizes both traditional ISM dosage forms (like kwatha, avaleha, bhasma, asava/arishta, churna) and modern pharmacopeial requirements (Ayurvedic/Unani/Siddha pharmacopoeias, analytical tests, quality control parameters). The questions probe deeper aspects such as standardization techniques, physicochemical assays, safety limits (heavy metals, microbial load), and specialized tests used for herbo-mineral preparations. These MCQs will help reinforce theoretical knowledge and prepare students for academic exams and professional practice in ISM quality assurance and regulatory affairs.

Q1. Which of the following is the most appropriate pharmacopeial parameter to assess adulteration or contamination by inorganic matter in a powdered herbal drug?

• Total ash value
• Alcohol soluble extractive value
• pH of aqueous extract
• Loss on drying

Correct Answer: Total ash value

Q2. Which traditional quality test is specifically used to evaluate fineness and degree of incineration of bhasmas in rasaushadhi practice?

• Varitara (floating) test
• Rekhapurnatva (finger furrow filling) test
• Kapha-pitta test
• Griha-pariksha (heating) test

Correct Answer: Rekhapurnatva (finger furrow filling) test

Q3. In Ayurvedic Pharmacopoeia monographs, which of the following combinations of tests is commonly specified for authenticated herbal raw drug evaluation?

• Macroscopy, microscopy, TLC/HPTLC fingerprint, ash values
• Only organoleptic evaluation and smell
• Particle size distribution and tensile strength
• Viscosity and refractive index only

Correct Answer: Macroscopy, microscopy, TLC/HPTLC fingerprint, ash values

Q4. For an Asava/Arishta (fermented herbal preparation), which pharmacopeial parameter is essential to determine acceptability and shelf-life?

• Alcohol content and microbial load
• Total ash and acid-insoluble ash
• Loss on drying at 105°C only
• Viscosity and particle size

Correct Answer: Alcohol content and microbial load

Q5. Which analytical technique is most suitable for establishing chemical fingerprinting and quantification of marker compounds in herbal formulations according to modern pharmacopeial standards?

• HPTLC/HPLC
• Refractive index measurement
• Color matching by organoleptic test
• Paper chromatography only

Correct Answer: HPTLC/HPLC

Q6. Which parameter distinguishes kwatha (decoction) from swarasa (expressed juice) in pharmacopeial specifications?

• Method of preparation and heat extraction versus mechanical expression
• Both are identical; no distinction in pharmacopeia
• Presence of oil droplets only in kwatha
• Kwatha has standardized alcohol content but swarasa does not

Correct Answer: Method of preparation and heat extraction versus mechanical expression

Q7. Which of the following is a critical test for avaleha (herbal jam/confection) to ensure product stability and microbial safety?

• Water activity (aw) and total microbial count
• Acid-insoluble ash and pH only
• Particle size distribution and friability
• Copper content by colorimetry only

Correct Answer: Water activity (aw) and total microbial count

Q8. In standardization of oils (Taila) and ghee/ghrita, which set of tests is most relevant in a pharmacopeial monograph?

• Acid value, peroxide value, saponification value, refractive index
• Loss on drying and total ash only
• Heavy metal assay only
• TLC fingerprint and moisture content only

Correct Answer: Acid value, peroxide value, saponification value, refractive index

Q9. Which parameter is preferentially used to estimate extractable active constituents from a herbal drug and appears in pharmacopeial standards?

• Extractive value (water/alcohol)
• Loss on ignition
• Bulk density
• Melting point

Correct Answer: Extractive value (water/alcohol)

Q10. For quality control of churna (powder) formulations, which test is most important to detect adulteration with sand or siliceous grit?

• Acid-insoluble ash
• Moisture content by Karl Fischer
• Alcohol soluble extractive
• Viscosity

Correct Answer: Acid-insoluble ash

Q11. Which of the following is a recognized modern approach to authenticate botanical identity when classical microscopy is inconclusive?

• DNA barcoding (molecular fingerprinting)
• Only organoleptic smell comparison
• Measuring refractive index of powdered drug
• Colorimetric pH strip test

Correct Answer: DNA barcoding (molecular fingerprinting)

Q12. Which test is commonly used in pharmacopeial monographs to estimate inorganic contamination due to siliceous soil or sand in herbal drugs?

• Acid-insoluble ash
• Total alcoholic extractive
• Loss on drying
• pH of 1% aqueous solution

Correct Answer: Acid-insoluble ash

Q13. Which regulatory pharmacopeial publication is the primary source for official monographs of Ayurvedic classical drugs in India?

• Ayurvedic Pharmacopoeia of India (API)
• British Pharmacopoeia (BP)
• United States Pharmacopeia (USP)
• European Pharmacopoeia (EP)

Correct Answer: Ayurvedic Pharmacopoeia of India (API)

Q14. For a herbo-mineral rasayana containing mercury/lead, which modern tests are essential under pharmacopeial safety evaluation?

• Heavy metals quantitative assay (Hg, Pb, As) and speciation where possible
• Only organoleptic and color tests
• Loss on drying and melting point tests
• Viscosity and surface tension

Correct Answer: Heavy metals quantitative assay (Hg, Pb, As) and speciation where possible

Q15. Which of the following is a typical pharmacopeial specification for acceptance of a prepared kwatha (decoction) regarding total solids?

• Specified percentage of total solids (TSS) or dry residue per volume
• No specification; kwatha must be translucent only
• Taste must be bitter only
• Color must be golden brown irrespective of solids

Correct Answer: Specified percentage of total solids (TSS) or dry residue per volume

Q16. Which microbial limit is most relevant for non-sterile ISM dosage forms like powders and semi-solids as per common pharmacopeial guidance?

• Total aerobic microbial count and absence of specified pathogens (E. coli, Salmonella, S. aureus)
• Only yeast count without bacterial enumeration
• No microbial testing required for traditional products
• Only fungal identification by microscopy

Correct Answer: Total aerobic microbial count and absence of specified pathogens (E. coli, Salmonella, S. aureus)

Q17. In standardizing an herbal extract, loss on drying is measured primarily to determine which attribute?

• Residual moisture content affecting stability and microbial growth
• Inorganic ash content
• Total phenolic content directly
• Particle size distribution

Correct Answer: Residual moisture content affecting stability and microbial growth

Q18. Which of the following modern tests is particularly important for detection of aflatoxin contamination in powdered herbal drugs stored under humid conditions?

• HPLC with fluorescence detection or LC-MS/MS for aflatoxin analysis
• Acid-insoluble ash only
• pH strip test of aqueous extract
• Refractive index measurement

Correct Answer: HPLC with fluorescence detection or LC-MS/MS for aflatoxin analysis

Q19. Which traditional ISM dosage form requires specification for fermentation end-point and is standardized by residual sugar and alcohol assay in pharmacopeial monographs?

• Asava/Arishta
• Churna
• Taila (medicated oil)
• Avaleha (medicated jam)

Correct Answer: Asava/Arishta

Q20. For quality assurance of Siddha/Unani/Ayurvedic formulations, which integrated approach is recommended by modern pharmacopeial guidance to ensure identity, purity, and potency?

• Organoleptic, macroscopic/microscopic, chromatographic fingerprinting, physicochemical assays, and safety tests (heavy metals, pesticides, microbes)
• Only traditional organoleptic and taste tests
• Single marker assay without fingerprinting
• Only heavy metal testing is sufficient

Correct Answer: Organoleptic, macroscopic/microscopic, chromatographic fingerprinting, physicochemical assays, and safety tests (heavy metals, pesticides, microbes)

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