Water for injection Hs Code

Water for injection harmonized system code

Product Overview Water for injection, classified under HS Code 300490, is a highly purified aqueous solution specifically prepared for pharmaceutical and medical use. Defined as sterile, pyrogen-free water intended primarily for the dissolution or dilution of substances administered by injection, it must comply with rigorous pharmacopeial standards such as USP, EP, or JP. Key characteristics include a conductivity generally below 1.1 µS/cm, total organic carbon (TOC) levels less than 0.5 ppm, and endotoxin content not exceeding 0.25 EU/mL, ensuring suitability for parenteral applications. Processing involves advanced purification techniques like reverse osmosis, deionization, and sterile filtration, culminating in aseptic filling under controlled environments. Within HS Code 300490, product subcategories cover water for injection in bulk, pre-filled syringes, and multi-dose vials, each distinguished by volume and packaging specifications. Commercially, this product serves critical roles in pharmaceutical manufacturing, clinical diagnostics, and medical device preparation. Its market positioning is anchored in compliance with stringent regulatory standards and the assurance of biocompatibility, rendering it indispensable for sterile pharmaceutical formulations and intravenous therapies. HS Code Classification & Trade Specifications The HS Code 300490 falls under Chapter 30: Pharmaceutical Products; specifically, Heading 3004, which encompasses medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses. The subheading 300490 precisely identifies “Other medicaments (excluding vaccines and goods of heading 3002 or 3005), put up for retail sale,” with water for injection categorized here due to its pharmaceutical application and presentation for injection use. This classification facilitates accurate customs declarations and tariff assessments aligned with the Harmonized System Convention administered by the World Customs Organization (WCO). Trade considerations dictate packaging in sterilized, airtight containers ranging from 10 mL ampoules to 5 L bulk containers, utilizing materials such as Type I glass or medical-grade plastics to maintain sterility and prevent contamination. Preservation relies on aseptic processing and cold-chain logistics, often at temperatures between 2-8°C to ensure stability and endotoxin control. Quality standards conform to international pharmacopeias and WHO guidelines, supporting compliance with WTO trade regulations and enabling seamless cross-border movement. Documentation typically includes certificates of analysis, sterilization validation, and batch traceability to meet import/export and regulatory requirements.

Water for injection Chapter Note

1.- This Chapter does not cover : (a) Foods or beverages (such as dietetic, diabetic or fortified foods, food supplements, tonic beverages and mineral waters), other than nutritional preparations for intravenous administration (Section IV); (b) Products, such as tablets, chewing gum or patches (transdermal systems), containing nicotine and intended to assist tobacco use cessation (heading 24.04); (c) Plasters specially calcined or finely ground for use in dentistry (heading 25.20); (d) Aqueous distillates or aqueous solutions of essential oils, suitable for medicinal uses (heading 33.01); (e) Preparations of headings 33.03 to 33.07, even if they have therapeutic or prophylactic properties; (f) Soap or other products of heading 34.01 containing added medicaments; (g) Preparations with a basis of plaster for use in dentistry (heading 34.07); (h) Blood albumin not prepared for therapeutic or prophylactic uses (heading 35.02); or (ij) Diagnostic reagents of heading 38.22. 2.- For the purposes of heading 30.02, the expression “immunological products” applies to peptides and proteins (other than goods of heading 29.37) which are directly involved in the regulation of immunological processes, such as monoclonal antibodies (MAB), antibody fragments, antibody conjugates and antibody fragment conjugates, interleukins, interferons (IFN), chemokines and certain tumor necrosis factors (TNF), growth factors (GF), hematopoietins and colony stimulating factors (CSF). 3.- For the purposes of headings 30.03 and 30.04 and of Note 4 (d) to this Chapter, the following are to be treated : (a) As unmixed products : (1) Unmixed products dissolved in water; (2) All goods of Chapter 28 or 29; and (3) Simple vegetable extracts of heading 13.02, merely standardised or dissolved in any solvent; (b) As products which have been mixed : (1) Colloidal solutions and suspensions (other than colloidal sulphur); (2) Vegetable extracts obtained by the treatment of mixtures of vegetable materials; and (3) Salts and concentrates obtained by evaporating natural mineral waters. 4.- Heading 30.06 applies only to the following, which are to be classified in that heading and in no other heading of the Nomenclature : (a) Sterile surgical catgut, similar sterile suture materials (including sterile absorbable surgical or dental yarns) and sterile tissue adhesives for surgical wound closure; (b) Sterile laminaria and sterile laminaria tents; (c) Sterile absorbable surgical or dental haemostatics; sterile surgical or dental adhesion barriers, whether or not absorbable; (d) Opacifying preparations for X-ray examinations and diagnostic reagents designed to be administered to the patient, being unmixed products put up in measured doses or products consisting of two or more ingredients which have been mixed together for such uses; (e) Placebos and blinded (or double-blinded) clinical trial kits for use in recognised clinical trials, put up in measured doses, even if they might contain active medicaments; (f) Dental cements and other dental fillings; bone reconstruction cements; (g) First-aid boxes and kits;(h) Chemical contraceptive preparations based on hormones, on other products of heading 29.37 or on spermicides; (ij) Gel preparations designed to be used in human or veterinary medicine as a lubricant for parts of the body for surgical operations or physical examinations or as a coupling agent between the body and medical instruments; (k) Waste pharmaceuticals, that is, pharmaceutical products which are unfit for their original intended purpose due to, for example, expiry of shelf life; and (l) Appliances identifiable for ostomy use, that is, colostomy, ileostomy and urostomy pouches cut to shape and their adhesive wafers or faceplates.