Dialysis Acid Concentrate (Hemodialysis Concentrate Part A — Liquid)
Pack Sizes Available
Product Description
Technical Specifications
- Product Type: Liquid hemodialysis acid concentrate (Part A); two-component dialysate preparation system (Part A + Part B bicarbonate + purified water); prepared by dialysis machine proportioning system in real time during treatment
- Formulation (per litre of concentrate): Sodium Chloride IP ~165g | Calcium Chloride IP ~8.10g | Potassium Chloride IP ~6.0g | Magnesium Chloride IP ~3.70g | Acetic Acid (Glacial) IP ~9.46g | Purified Water IP q.s. (values per 1:34 formulation — confirmed from Shubham Exports Part A IFU)
- Mixing Ratio and Final Dialysate: 1:34 ratio: 1 volume Part A + 34 volumes purified water + 1.83 volumes reconstituted Part B; 1:44 ratio also available; ready-to-use dialysate: Na+ 136, K+ 2.2, Ca2+ 1.5, Mg2+ 0.5, Cl- 103, acetate 4.5 mmol/L
- Pack Sizes: 5 litre jerry can | 10 litre jerry can | 20 litre bulk container; acid concentrate containers labelled red per international convention; sealed with tamper-evident closure
- Storage: Store at 15-25°C; keep away from direct sunlight and heat; do not freeze; shelf life 12-24 months from manufacture (per batch label); use opened containers promptly; do not mix different batch numbers
- Compliance and Standards: Formulated to European Pharmacopoeia, British Pharmacopoeia, and USP standards for hemodialysis concentrate; ISO 23500 series compliance; CDSCO registered (India); drug manufacturing licence applicable; for use in haemodialysis machines only per machine manufacturer specifications
Frequently asked questions
Hemodialysis dialysate — the solution that flows through the dialyser machine during a hemodialysis session — cannot be supplied as a single pre-mixed concentrate because the calcium, magnesium, and potassium in the electrolyte portion would precipitate out of solution if mixed directly with bicarbonate at high concentrations. Instead, dialysate is prepared from two separate concentrates: Part A (acid concentrate) containing electrolytes and an acidifying agent (acetic or citric acid), and Part B (bicarbonate concentrate) containing sodium bicarbonate. The dialysis machine proportions both concentrates with purified water to produce the final dialysate in real time. The acid component (Part A) is so named because its acidic pH (due to acetic acid) keeps calcium and magnesium in solution and prevents precipitation when mixed with water.
Standard hemodialysis acid concentrate (Part A) contains the following electrolytes per litre of concentrate: Sodium Chloride IP approximately 165g (providing the dialysate sodium); Calcium Chloride IP approximately 8.10g (providing physiological dialysate calcium of approximately 1.5 mmol/L in final dialysate); Potassium Chloride IP approximately 6.0g (providing dialysate potassium of approximately 2.0-2.2 mmol/L, adjustable per patient prescription); Magnesium Chloride IP approximately 3.70g (providing dialysate magnesium of approximately 0.5 mmol/L); Acetic Acid (Glacial) IP approximately 9.46g (acidifying agent, prevents precipitation, contributes to acetate buffer); Dextrose IP (in glucose-containing formulations). All quantities confirmed from Shubham Exports Part A formulation with 1:34 dilution ratio. Ready-to-use dialysate electrolyte targets: Na+ 136, Ca2+ 1.5, K+ 2.2, Mg2+ 0.5, Cl- 103, acetate 4.5 mmol/L.
Hemodialysis acid concentrate is supplied at a specific concentration factor that must be diluted to the correct ratio by the dialysis machine proportioning system. The two most common ratios are: 1:34 ratio — one volume of acid concentrate is mixed with 34 volumes of purified water plus 1.83 volumes of reconstituted Part B bicarbonate concentrate. This is the older, traditional ratio used by many legacy dialysis machines. 1:44 ratio — one volume of acid concentrate is mixed with 44 volumes of purified water plus bicarbonate. This is the more modern ratio used by many current-generation dialysis machines including those from Nipro and Fresenius. The mixing ratio must match the dialysis machine's proportioning system specification exactly. Incorrect ratio matching produces dialysate with wrong electrolyte concentrations, which is clinically dangerous. Always confirm the machine ratio specification before supplying concentrate.
Hemodialysis acid concentrate (Part A) is supplied in sealed jerry cans or rigid containers in 5-litre and 10-litre formats, with 20-litre bulk containers available for large-volume dialysis centres. By international convention, acid concentrate containers (Part A) are labelled in red — a colour-coding system widely followed across dialysis supply chains to prevent the potentially dangerous confusion of mixing Part A and Part B incorrectly. Part B bicarbonate concentrates are typically labelled in blue or white. Each container label includes the product name, composition, dilution ratio, batch number, expiry date, storage conditions, and manufacturer details. Containers must be stored upright in a cool, dry environment away from direct sunlight.
Dialysis acid concentrate (Part A) should be stored in a cool, dry environment at room temperature (15-25°C), away from direct sunlight and heat sources. Freezing should be avoided as it can affect concentrate homogeneity and electrolyte distribution. Shelf life is typically 12-24 months from manufacture when stored under correct conditions (specific shelf life is stated on each batch label). Once opened, the container should be used promptly and any unused concentrate from an opened container should be used within a defined period as specified by the manufacturer. Opened containers should not be combined with contents from different batch numbers. Expired concentrate must not be used as electrolyte concentrations may have shifted outside specification.
Dialysis acid concentrate for hemodialysis use is formulated and manufactured in compliance with: European Pharmacopoeia (Ph. Eur.) monograph for Haemodialysis Concentrate Solutions; British Pharmacopoeia (BP) standards for hemodialysis concentrate; United States Pharmacopeia (USP) hemodialysis concentrate requirements; ISO 23500 series (Preparation and quality management of fluids for hemodialysis and related therapies); and applicable CDSCO (Central Drugs Standard Control Organisation) registration requirements for dialysis concentrates in India. Manufacturers in India exporting hemodialysis concentrate must hold appropriate drug manufacturing licences and product registrations. Sara Wellness works with licensed manufacturers whose products are formulated to meet international pharmacopoeia standards.
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