Bill of Materials & Batch Composition Calculator – Parenteral
- Purpose: This calculator assists in preparation of parenteral batch composition and bill of materials by calculating raw materials, primary packing materials, and miscellaneous materials requirements. It generates a detailed batch composition table ready for review, printing, or export.
- Enter the Product Name for identification and print records.
- Enter the Target Fill Volume (mL) and Batch Size (Liter). These fields are mandatory. The calculator automatically calculates the approximate Batch Size (Number of Units).
- Raw Materials Part:
- Enter details for API, excipients, and vehicle required for the formulation.
- Select Type = API for Active Pharmaceutical Ingredient. For a single API lot, enter the Assay (as-is) % directly in the Assay field. If multiple API lots are intended for manufacturing, click "Click for Multiple API Lots Only" button and enter the available quantity and Assay (as-is) % for each API lot. The calculator will automatically determine the lot-wise API distribution required to meet the batch requirement.
- If the assay is reported on Dried, Anhydrous, or Ignited basis in the COA, first convert it to Assay (as-is basis) % using our 🔗 Assay (as-is) for Active Pharmaceutical Ingredient Calculator . The calculated Assay (as-is basis) % should then be entered for the respective API lot.
- For single-lot API calculations, the calculator automatically adjusts API quantity using: Corrected Qty = (Entered Qty × 100) ÷ Assay (as-is basis) %.
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For multi-lot API calculations, the calculator allocates API lot-wise based on available quantity and assay, and reports:
- Lot-wise available and allocated physical quantities of each API lot
- Lot-wise pure API equivalent quantity contributed based on Assay (as-is) %
- Lot-wise remaining quantity after allocation
- Total available and total allocated quantities for the batch
- Total pure API equivalent required and allocated quantities for the batch
- Material availability verification status and any shortage (pure API equivalent), if applicable
- Select Type = Vehicle for formulation vehicles such as Water for Injection (WFI) or suitable solvents.
- For materials requiring q.s. handling, tick the q.s. checkbox.
- Enter Overage % wherever applicable.
- Primary Packing Materials Part:
- Enter primary packaging components such as ampoules, vials, rubber stoppers, flip-off seals, syringe components, or other primary packaging materials.
- The calculator automatically calculates:
- Qty/Batch (Theoretical) based on calculated units.
- Qty/Batch (Required) after applying overages.
- Enter Overage % wherever applicable.
- Miscellaneous Materials Part:
- Enter additional process materials such as filters, tubing, nitrogen, or other consumables as required.
- Click Calculate & Show Table to generate the bill of materials & batch composition table.
- Use Export to save as CSV/Excel or Print / Save as PDF to generate a report. Always review the printed or exported report for correctness before use.
Cakk Magg X Pharmaceutical Services | www.cakkmaggx.com | info@cakkmaggx.com
Multiple API Lots Breakdown
| Lot Number | Available API Qty * | Unit * | Assay (as-is) (%) * | Action |
|---|