Batch Manufacturing Formula Scaling Calculator
From mg per tablet to kg per batch, with the filler that keeps the weight and the BOM.
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- Free preview: the method, the limits that apply and the verdict for your input; computed figures stay hidden until the pass.
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Batch formula and bill of materials
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About the Batch Manufacturing Formula Scaling Calculator
Scales a unit formula — the milligrams of each ingredient in one tablet, capsule, sachet or millilitre — to the quantities of a batch of any size. Each API gets its overage and its potency as is, and the extra weight they need is taken off one filler, so the batch weight stays as the formula sets it; every quantity is rounded to the readability of the balance that weighs it, APIs upwards; solvents removed in processing are dispensed but left out of the weights. The bill of materials adds the packaging, with an allowance for losses.
The report checks that the formula adds up to the target unit weight and that the filler can take the compensation. Without a pass it shows a free preview: the method, the limits and the verdicts, with the computed quantities hidden; the quantities, the PDF, the XLSX file, the printed copy and the copied text unlock with a Premium pass.
How to use it
- Enter the batch size and its unit, and the target unit weight if you want the formula checked against it.
- Enter the unit formula, one ingredient per row: its role (API, filler, excipient, coating or solvent) and its quantity per unit in mg; paste the rows from a spreadsheet if you have them.
- For each API, add its overage and its potency as is; mark the filler that takes the compensation.
- Pick the balance readability of each ingredient (0.001 g on an analytical balance, 0.01 kg on a platform balance) or keep the batch default.
- Add the packaging, such as cartons, leaflets or labels, with the quantity per pack, the units per pack and an allowance.
- Read the verdict and the checks. Without a pass the report stays a free preview with its quantities hidden; the PDF, XLSX, print and copy unlock with a Premium pass.
Examples
Paracetamol 500 mg (potency 99.2% as is, weighed to 0.01 kg) · microcrystalline cellulose 60 mg (filler) · povidone 15 mg · croscarmellose 18 mg · magnesium stearate 5 mg · colloidal silica 2 mg · purified water 120 mg (removed)
Paracetamol 100.81 kg · cellulose 11.19 kg · povidone 3,000.0 g · batch weight 120 kg, standard and dispensed · 24 kg of water dispensed
500 mg × 200,000 = 100 kg; ÷ 0.992 = 100.806 kg, rounded up to 100.81 kg; the 0.81 kg comes off the 12 kg of cellulose.
200,000 tablets · 1 carton and 1 leaflet per pack of 100 · allowance 2%
2,000 packs · 2,040 cartons and 2,040 leaflets
Cyanocobalamin 1 mg per tablet · overage 30% · potency 97% · 1,000 tablets · weighed to 0.001 g
1.341 g to dispense (1,340.206 mg rounded up)
Common uses
- Production planning issuing the batch formula and bill of materials for a new batch size.
- Formulation scientists scaling a laboratory formula to pilot and commercial batches.
- Stores and purchase working out the raw and packing materials a batch needs.
- Quality assurance checking the arithmetic of a batch manufacturing record.
How the batch is worked out
- Standard quantity: S = quantity per unit × N, with N the batch size in units.
- API to dispense: Q = S × (1 + overage ÷ 100) × 100 ÷ potency as is, rounded up to its balance readability.
- Compensation: C = Q − S for each API; the filler to dispense is its standard quantity less the sum of C, rounded to the nearest step.
- Other ingredients: their standard quantity, rounded to the nearest step of their balance.
- Weights: the batch and unit weights leave out solvents removed in processing (purified water in wet granulation, solvents of a coating suspension); the coating counts in the unit weight.
- Packaging: packs = N ÷ units per pack, rounded up; each material = packs × quantity per pack × (1 + allowance ÷ 100), whole pieces rounded up.
Overage, potency and the filler
An overage is a deliberate excess of an API, stated in the master formula, to make up for a known loss in manufacture or on storage; potency compensation makes up for a lot with less than 100% of the API as it is weighed. Both make the API heavier than its theoretical quantity, and taking that weight off one filler keeps the batch weight, and so the weight of each tablet, where the formula sets it. If your master formula’s API quantity already includes the overage, enter 0 overage here.
The rules behind the report
- 21 CFR Part 211, section 211.186(b): the master production record states the weight or measure of each component, any calculated excess of a component, and the theoretical weight at the appropriate phases of processing.
- Section 211.101(a): a batch is formulated to provide not less than 100% of the labelled amount of active ingredient, which is why each API is rounded up.
- Section 211.101(c): each container dispensed is checked by a second person against the batch record, or by one person when automated equipment under section 211.68 does the weighing.
These are the United States rules; other regulators have equivalent requirements. Follow your own approved procedures.
Limitations
- A calculation aid: check the batch formula against the approved master formula before it is issued.
- One filler takes the compensation; formulas that share it between several excipients need the master formula’s own rule.
- It does not convert between volume and mass: give liquids in mg per unit, or work in mL with a density outside the tool.
- Packaging quantities count whole packs; partial packs, samples and line losses beyond the allowance are not modelled.
- It is not a validated computerised system for GMP records.
Privacy
On this device; its files download once
Everything happens in your browser. What you enter or open here is not uploaded or stored by MySmartCoPilot. Only the PDF and XLSX exports load their engines and fonts from this site the first time; your formula never leaves this browser.
Frequently asked questions
What do I get without a pass?
Without a pass, Batch Manufacturing Formula Scaling Calculator shows the method, the limits that apply and the verdict for your input; computed figures stay hidden until the pass. Until you unlock it, the result can’t be downloaded, copied or printed. A Premium or Ultimate pass, a one-time payment that never renews, unlocks the full result. The pricing page lists the passes and their prices.
What does the free preview show?
Your unit formula, the roles and readabilities, the method, the limits and every verdict, with the checks in words. The computed quantities — each standard, the compensation, the quantities to dispense, the batch weights and the bill of materials — show as “•••”; they, the PDF, the XLSX file, the printed copy and the copied text unlock with a Premium pass.
How do I convert a unit formula to a batch formula?
Multiply each ingredient’s quantity per unit by the number of units: 500 mg × 200,000 tablets = 100,000,000 mg = 100 kg. Then adjust the APIs for overage and potency and take the difference off the filler.
Why is only the API rounded up?
Rounding the API up keeps not less than 100% of the labelled amount in the batch, as 21 CFR 211.101(a) intends; the other ingredients are rounded to the nearest step of their balance.
Where does the potency as is come from?
From the API’s certificate of analysis: the assay on the anhydrous or dried basis × (100 − water or LOD) ÷ 100, with the salt-to-base factor where the label claim is of the base. The API dispensing calculator works it out step by step.