Export of alcoholic preparations MCQs With Answer

Export of alcoholic preparations MCQs With Answer is an essential study resource for B.Pharm students focusing on international trade, regulatory compliance, quality control, and safe handling of ethanol-based formulations. This introduction highlights export documentation (commercial invoice, packing list, COA, certificate of origin), licensing and NOC requirements, customs and HS codes, labelling and packaging norms, analytical testing (GC, headspace GC, GC‑MS), flammability and transport rules (UN numbers, hazard class, packing groups), excise/tax implications, storage and stability, and practical export procedures. Answers include explanations to reinforce practical recall and exam readiness. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary commercial document required to declare the value and description of exported alcoholic preparations?

• Commercial invoice
• Prescription
• Manufacturing record
• Material Safety Data Sheet

Correct Answer: Commercial invoice

Q2. Which document provides detailed analytical specifications and batch results for a consignment?

• Certificate of Analysis (COA)
• Certificate of Origin
• Certificate of Free Sale
• Bill of Lading

Correct Answer: Certificate of Analysis (COA)

Q3. Which analytical technique is most appropriate for accurate quantification of ethanol and volatile impurities in alcoholic preparations?

• Gas chromatography (GC)
• High-performance liquid chromatography (HPLC)
• Titration with silver nitrate
• UV-Visible spectrophotometry

Correct Answer: Gas chromatography (GC)

Q4. What is the UN number commonly assigned to ethanol (ethyl alcohol) for transport?

• 1170
• 1090
• 1263
• 3082

Correct Answer: 1170

Q5. Under the UN classification of dangerous goods, ethanol is placed in which hazard class?

• Class 3 (Flammable liquids)
• Class 6 (Toxic substances)
• Class 8 (Corrosive substances)
• Class 9 (Miscellaneous dangerous goods)

Correct Answer: Class 3 (Flammable liquids)

Q6. Which Incoterm is defined by the seller delivering goods on board the ship at the named port of shipment?

• FOB (Free On Board)
• CIF (Cost, Insurance & Freight)
• EXW (Ex Works)
• DDP (Delivered Duty Paid)

Correct Answer: FOB (Free On Board)

Q7. Why is an HS (Harmonized System) code important when exporting alcoholic preparations?

• To classify goods for customs duty and statistical purposes
• To indicate expiry date
• To certify microbial safety
• To specify packaging material

Correct Answer: To classify goods for customs duty and statistical purposes

Q8. What is the purpose of a Certificate of Free Sale in pharmaceutical exports?

• To confirm the product is permitted for sale in the exporting country
• To document the route of shipment
• To guarantee delivery dates to the importer
• To identify hazardous waste disposal method

Correct Answer: To confirm the product is permitted for sale in the exporting country

Q9. Why are pharmaceutical ethanol products often denatured before export?

• To render them unsuitable for beverage consumption and avoid beverage taxes
• To increase their therapeutic potency
• To improve solubility of active ingredients
• To reduce flammability

Correct Answer: To render them unsuitable for beverage consumption and avoid beverage taxes

Q10. Which type of packaging is typically required for bulk export of flammable alcoholic preparations to meet transport safety standards?

• UN‑approved metal drums or approved intermediate bulk containers (IBCs)
• Paper sacks with plastic liners
• Open wooden crates
• Cardboard boxes without inner liners

Correct Answer: UN‑approved metal drums or approved intermediate bulk containers (IBCs)

Q11. Which information must appear on transport labels for exported flammable alcoholic preparations?

• UN number and hazard class
• Recommended retail price
• Manufacturer’s bank account details
• List of excipients only

Correct Answer: UN number and hazard class

Q12. What is the main objective of stability testing for exported alcoholic pharmaceutical formulations?

• To establish shelf life and ensure quality throughout storage and transit
• To certify market price competitiveness
• To test for color preferences in target markets
• To measure packing density for shipping

Correct Answer: To establish shelf life and ensure quality throughout storage and transit

Q13. Which authority typically issues export licences or approvals for pharmaceutical products in a country?

• National drug regulatory authority (e.g., central medicines regulator)
• Local chamber of commerce
• International Monetary Fund
• World Health Organization

Correct Answer: National drug regulatory authority (e.g., central medicines regulator)

Q14. What is the primary function of a Bill of Lading in sea shipments of alcoholic preparations?

• It serves as a receipt for goods and a contract of carriage
• It certifies product purity
• It is used to calculate local taxes
• It provides laboratory test results

Correct Answer: It serves as a receipt for goods and a contract of carriage

Q15. Which quality test is important to confirm the microbiological safety of tinctures and alcoholic herbal extracts?

• Microbial limit test
• Tablet disintegration test
• Viscosity measurement
• Friability test

Correct Answer: Microbial limit test

Q16. What does an excise duty drawback scheme provide for exporters of alcoholic preparations?

• Refund of customs or excise duties paid on goods that are exported
• Permanent exemption from all taxes on domestic sales
• Automatic export licence for all products
• Subsidized freight rates

Correct Answer: Refund of customs or excise duties paid on goods that are exported

Q17. Ideal storage conditions for exported ethanol-based pharmaceutical products include which precaution?

• Store in a cool, well-ventilated area away from ignition sources
• Store in direct sunlight to reduce microbial load
• Store at elevated temperatures to maintain fluidity
• Store submerged in water to prevent evaporation

Correct Answer: Store in a cool, well-ventilated area away from ignition sources

Q18. Which document certifies the country of manufacture of an exported pharmaceutical batch?

• Certificate of Origin
• Bill of Lading
• MSDS
• Purchase Order

Correct Answer: Certificate of Origin

Q19. Which international guideline specifically addresses Good Manufacturing Practices relevant to pharmaceutical exports?

• WHO Good Manufacturing Practices (WHO GMP)
• ISO 9001:2015
• HACCP (Food safety)
• GLP (Good Laboratory Practice)

Correct Answer: WHO Good Manufacturing Practices (WHO GMP)

Q20. What is the main role of a Certificate of Pharmaceutical Product (CPP) in international trade?

• To provide evidence that the product is authorized for sale in the exporting country and facilitate registration abroad
• To list all distributors in the importing country
• To serve as a packing instruction for shippers
• To replace the need for a COA

Correct Answer: To provide evidence that the product is authorized for sale in the exporting country and facilitate registration abroad

Q21. Which GHS pictogram is used on labels for flammable alcoholic products?

• Flame pictogram
• Skull and crossbones pictogram
• Corrosion pictogram
• Environment pictogram

Correct Answer: Flame pictogram

Q22. Which packing group corresponds to substances presenting high danger and requiring the most stringent packaging?

• Packing Group I
• Packing Group II
• Packing Group III
• Packing Group IV

Correct Answer: Packing Group I

Q23. Which analytical method is preferred to detect and quantify residual solvents such as methanol in exported ethanol preparations?

• Headspace gas chromatography (Headspace GC)
• High-performance liquid chromatography (HPLC)
• Fourier-transform infrared spectroscopy (FTIR)
• Gravimetric analysis

Correct Answer: Headspace gas chromatography (Headspace GC)

Q24. Which export document is commonly used as the customs declaration for exported goods and is often required to claim duty drawback?

• Shipping bill / export declaration
• Proforma invoice
• Prescription copy
• Purchase order

Correct Answer: Shipping bill / export declaration

Q25. What practical packaging measure reduces alcohol vapor loss and maintains concentration during transport?

• Using tight-sealing containers with vapor‑tight closures and proper liners
• Packing in porous paper sacks
• Leaving containers partially open to equilibrate pressure
• Using non-sealed wooden barrels without linings

Correct Answer: Using tight-sealing containers with vapor‑tight closures and proper liners

Q26. To specifically confirm and quantify toxic methanol contamination in an ethanol batch, which technique is most definitive?

• Gas chromatography-mass spectrometry (GC-MS)
• Colorimetric paper strip test
• Simple density measurement
• pH testing

Correct Answer: Gas chromatography-mass spectrometry (GC-MS)

Q27. What is the purpose of a No Objection Certificate (NOC) in the export of certain alcoholic pharmaceutical products?

• To grant regulatory permission for exporting controlled or restricted substances
• To certify the lowest export price
• To confirm receipt by the importer
• To replace the COA

Correct Answer: To grant regulatory permission for exporting controlled or restricted substances

Q28. Which document is used for air shipments of pharmaceutical alcoholic preparations?

• Air Waybill (AWB)
• Bill of Lading (ocean)
• CMR note (road)
• TIR Carnet

Correct Answer: Air Waybill (AWB)

Q29. Why must exported alcoholic preparations display concentration (% v/v) on the label?

• To ensure correct dosing, safe handling, and regulatory compliance
• To advertise potency compared to competitors
• To indicate manufacturing cost
• To show preferred storage temperature only

Correct Answer: To ensure correct dosing, safe handling, and regulatory compliance

Q30. Which regulatory document is commonly required by importing countries to demonstrate that the manufacturing site complies with good manufacturing practices?

• GMP certificate / inspection report
• Invoice copy
• Transport insurance policy
• Local market advertisement

Correct Answer: GMP certificate / inspection report

Download