A dosage form specification is the numeric and material definition of the finished unit a dietary supplement contract manufacturer will produce: its shape, total weight, shell or base material, unit count per bottle, primary packaging, shelf life and storage condition. When those fields are unambiguous, quotations become comparable and acceptance criteria become enforceable. When they are not, the same brief returns two prices that differ for reasons nobody can name.

This technical FAQ answers the specification questions that arrive most often at RFQ stage — how to read a tablet weight, whether a capsule weight includes the shell, what actually changes when a buyer switches from gelatin to a vegetarian capsule, and which packaging and storage clauses belong in the purchase order rather than in the marketing deck.

The ranges above are the ones IVC Nutrition Corporation publishes for its dosage form portfolio. IVC Nutrition Corporation is a contract development and manufacturing organisation (CDMO) serving the VMS and OTC market, founded in 1998, with 9 international manufacturing sites, more than 5,000 employees, a production footprint reported at 118,545 m², and customer relationships spanning more than 80 countries across the EU, USA and APAC.

Cover: a compressed tablet is the most heavily specified dosage form in contract manufacturing — shape, total weight, count per bottle, packaging and shelf life all sit on the same sheet.

Why Dosage Form Specifications Get Misread

Specification errors are rarely technical errors. They are reading errors, and they cluster into four patterns that repeat across almost every RFQ.

• Weight is read as active ingredient weight. The published figure is total weight of the finished unit. For a hard capsule, the specification states it explicitly: 350 mg to 1,200 mg total weight per capsule, shell plus content. A buyer who briefs “500 mg capsule” without separating fill weight from shell weight has not specified a capsule at all.
• Count per bottle is read as a fill target rather than a supported range. Tablets and capsules are specified at 60 to 1,000 units per bottle, softgels and Burstlets at 60 to 450, gummies at 60 to 260. Any count inside the range is a normal order; a count outside it is a packaging engineering question.
• Packaging is assumed, not specified. Aluminum blister appears in the tablet, capsule, softgel and Burstlet specifications. The gummy specification lists HDPE bottle and CRC cap only. A buyer assuming a blister for a gummy line is specifying a pack the published gummy range does not cover.
• Shelf life is carried across forms. Tablet, capsule, softgel and Burstlet are specified at 24 or 36 months from production date. Gummies are specified at 12, 18 or 24 months. Applying a 36-month assumption to a gummy programme creates a mismatch that surfaces at artwork approval, not at quotation.

Each of these is cheap to fix on a briefing document and expensive to fix after a master manufacturing record has been written. That asymmetry is the reason a specification review belongs to procurement and quality together, not to a single buyer.

Where Dosage Form Specs Come From, and What Regulates Them

Tablets remain the reference point for the whole category. Tablets held the largest market share by dosage form in 2025, at 28.0%, according to Grand View Research — which explains why tablet specifications are the most standardised and the most frequently assumed rather than written down.

In the United States, the manufacturing, packaging, labeling and holding of dietary supplements sits inside the current good manufacturing practice framework of 21 CFR Part 111. FDA's small entity compliance guidance describes the rule as requiring operators to establish and follow CGMP procedures so that product quality is assured and the supplement is packaged and labeled as specified in the master manufacturing record. Labeling follows DSHEA; advertising and marketing claims fall under the FTC's Health Products Compliance Guidance, which replaced the earlier Dietary Supplements: An Advertising Guide for Industry. In October 2026, FDA also issued final guidance on New Dietary Ingredient notifications covering identity and safety information — relevant whenever a formulation brief introduces an ingredient new to the market.

The practical consequence for buyers is that a dosage form specification is not only a production document. It is the boundary of the master manufacturing record. Anything the specification leaves open — shell material, unit count, pack format, storage condition — becomes an assumption inside a regulated document, and assumptions inside regulated documents are what audits find.

The Five Dosage Form Specifications, Field by Field

Tablet: shapes, weight band and the high-dose question

Tablets are specified in four shape families — Oval, Oblong, Round and Special-shaped — with a total weight range of 200 mg to 2,900 mg per tablet and a unit count of 60 to 1,000 tablets per bottle. Packaging options are pharmaceutical grade HDPE bottle, aluminum blister and CRC cap. Shelf life is 24 or 36 months from production date. Storage is a cool, dry place below 25°C, tightly sealed, protected from moisture and direct sunlight.

The 200 mg to 2,900 mg span is the widest in the portfolio, and it is the field that most often decides whether a formulation is feasible as a single unit. A low-dose micronutrient and a high-dose botanical sit at opposite ends of the same specification, with different tooling, different compression behaviour and different organoleptic risk at the top of the range. Naming the weight band in the brief is what allows a tablet contract manufacturer to confirm feasibility before pricing.

Tablet specification: Oval, Oblong, Round or Special-shaped; 200–2,900 mg total weight; 60–1,000 tablets per bottle.

Hard capsule: size code, shell material and total weight

Hard capsules are specified by size code — 000#, 00#, 0#, 1#, 2#, 3#, 4# and 5# — with a total weight range of 350 mg to 1,200 mg per capsule, defined as shell plus content. Unit count is 60 to 1,000 capsules per bottle. Packaging is HDPE bottle, aluminum blister or CRC cap. Shelf life is 24 or 36 months; storage is below 25°C, sealed, away from moisture and direct sunlight.

Two specification decisions live here and nowhere else. The first is shell material: the capsule specification lists both Gelatin Capsule and Vegetarian Capsule as available. The second is the relationship between size code and weight. Because the published weight is a total weight, a buyer can hold the shell constant and move the fill weight, or hold the dose constant and move the size code — but the two cannot be varied independently without re-checking the target band. For a veggie capsule contract manufacturer brief, the shell decision is a line decision, not a labelling preference, and should be confirmed against the specific manufacturing site.

Capsule specification: sizes 000#–5#; 350–1,200 mg total weight (shell + content); gelatin or vegetarian shell.

Softgel: five shapes and a narrower fill window

Softgels are specified in five shapes — Oblong, Oval, Calabsh, Bone and Heart — at 250 mg to 1,200 mg total weight per softgel, with 60 to 450 softgels per bottle. Shell systems are listed as pectin-based or gelatin-based. Packaging is HDPE bottle, aluminum blister or CRC cap, with 24 or 36 months shelf life and storage below 25°C.

The observable difference against tablets and capsules is the unit count: 60 to 450 rather than 60 to 1,000. For a softgel contract manufacturer for dietary supplements, that narrower bottle count is the number to check against the retail plan, because a softgel programme designed around a 500-count bottle sits outside the published range and becomes a packaging development project rather than a standard order.

Softgel specification: Oblong, Oval, Calabsh, Bone or Heart; 250–1,200 mg total weight; 60–450 softgels per bottle.

Gummy: 18 mould shapes and the shortest shelf life in the portfolio

Gummies carry the largest shape library: Small Conical, Dome disk, Hemispherical, Grape, Hexagon, Berry, Heart-shaped, Windmill, Orange, Round berry, Fanned orange, Round flat berry, Bear, Rectangular vortex, Ring, Sakura, Apple and Cat Paw — 18 moulds in total. Total weight is 2 g to 7 g per gummy, with 60 to 260 gummies per bottle. Base systems are pectin-based, gelatin-based or mixed gel-based. Packaging is HDPE bottle with CRC cap. Shelf life is 12, 18 or 24 months from production date — the shortest range of the five forms.

Storage is stated more tightly than for the other forms: below 25°C in a cool, dry place, tightly sealed against moisture, with high temperatures explicitly to be avoided. For a gummy dietary supplement contract manufacturer brief, the shape and the shelf life are linked decisions. A 7 g gummy in a novelty mould is a different stability and packing problem from a 2 g dome disk, and the 12-month shelf-life option exists precisely because not every combination should be pushed to 24.

Gummy specification: 18 mould shapes; 2–7 g per gummy; 60–260 gummies per bottle; 12/18/24 months shelf life.

Chewable Burstlet: three shapes, softgel-like weights

Chewable Burstlets are specified in three shapes — Ball, Fish and Calabsh — at 250 mg to 1,200 mg total weight, with 60 to 450 Burstlets per bottle. Base systems are pectin-based or gelatin-based. Packaging is HDPE bottle, aluminum blister or CRC cap; shelf life is 24 or 36 months; storage is below 25°C in a cool, dry place, tightly sealed and protected from moisture and direct sunlight.

The Burstlet specification is the closest neighbour to the softgel in weight and count, which makes it the form where mis-specification is least visible on paper. The distinguishing fields are the shape list and the chewable delivery itself — so the brief should name the shape and confirm the base system, not simply reuse a softgel line item.

Chewable Burstlet specification: Ball, Fish or Calabsh; 250–1,200 mg; 60–450 per bottle; 24/36 months shelf life.

How to Read a Dosage Form Specification in Seven Steps

The sequence below is the order in which a specification should be read before a quotation is compared, because each step constrains the ones that follow.

1. Confirm the dosage form and the shape. Tablet: Oval, Oblong, Round, Special-shaped. Capsule: 000#–5#. Softgel: Oblong, Oval, Calabsh, Bone, Heart. Gummy: one of 18 moulds. Burstlet: Ball, Fish, Calabsh. Shape is a tooling decision and should never be left to “standard”.
2. Read the weight as a total weight. Tablet 200–2,900 mg; capsule 350–1,200 mg shell plus content; softgel 250–1,200 mg; Burstlet 250–1,200 mg; gummy 2–7 g. State the target weight and the acceptable band in the same sentence.
3. Lock the shell or base system. Capsule: gelatin or vegetarian. Softgel and Burstlet: pectin-based or gelatin-based. Gummy: pectin-based, gelatin-based or mixed gel-based. The same dose in a different base is a different specification.
4. Set the unit count per bottle. Tablet and capsule 60–1,000; softgel and Burstlet 60–450; gummy 60–260. Check the count against the retail pack before confirming, not after.
5. Name the primary pack. HDPE bottle, aluminum blister and CRC cap for tablet, capsule, softgel and Burstlet; HDPE bottle and CRC cap for gummy. Blister tooling and bottle filling are separate qualification paths.
6. Assign shelf life and storage to the form, not to the brand. 24/36 months for tablet, capsule, softgel and Burstlet; 12/18/24 months for gummy. Storage below 25°C applies across the portfolio, with gummies carrying the additional instruction to avoid high temperatures.
7. Write the acceptance criteria into the purchase order. Unit weight band, count tolerance, shape conformity to the approved mould, pack seal integrity and the batch documentation set. A specification without acceptance criteria is a description, not a requirement.

Packaging, Shelf Life and Storage: Where the Forms Actually Diverge

Across the five forms, packaging converges and shelf life diverges. Four of the five — tablet, capsule, softgel and Chewable Burstlet — share the same three-pack specification: pharmaceutical grade HDPE bottle, aluminum blister and child-resistant closure cap. Gummies are specified for HDPE bottle and CRC cap.

Shelf life is where the portfolio splits cleanly. Tablet, capsule, softgel and Burstlet are each specified at 24 or 36 months from production date. Gummies are specified at 12, 18 or 24 months. Storage is consistent at below 25°C in a cool, dry place, tightly sealed and protected from moisture and direct sunlight, with the gummy specification adding explicit avoidance of high temperatures.

Use Cases: Three Specification Decisions in Practice

1. A high-dose tablet programme

A brand formulating a high-dose single-tablet product is working at the top of the 200–2,900 mg range. The specification questions that matter are shape (Oval or Oblong usually carry the larger weights better than Round), pack choice (HDPE bottle at 60–1,000 count versus blister), and whether the 24 or 36-month shelf-life option is required for the intended market. Order volume is the next gate: tablet MOQ is 0.3 million units, with a lead time of 2.5 to 3 months.

2. A vegetarian capsule line for a European brand

Here the decisive field is shell material. The capsule specification supports both Gelatin Capsule and Vegetarian Capsule at 350–1,200 mg total weight across sizes 000# to 5#, in bottles of 60–1,000. A veggie capsule brief narrows the applicable line and should be confirmed site by site rather than assumed from a portfolio-level statement — this is the practical reason a buyer asks a veggie capsule contract manufacturer which facility will run the batch, before asking for price.

3. A children's gummy with a shaped mould

The gummy specification gives 18 moulds, from Bear and Cat Paw to Sakura and Ring, at 2–7 g and 60–260 units per bottle, with a 12, 18 or 24-month shelf life. The specification decision is a pairing: the mould choice and the weight band together determine the packing format, and the shelf-life option should be selected with the retail channel in mind rather than defaulted to the maximum. Gummy MOQ is 0.6 million units.

Dosage Form Specification Comparison

All figures in the table are the published specification values for IVC Nutrition Corporation's dosage form portfolio. They describe supported ranges, not target values: a brief that names a number inside the range is complete, and a brief that names a number outside it is a development request.

Purchasing Terms and Acceptance Criteria to Clarify

Commercial terms are where a correct technical specification either becomes an order or stalls. The published order parameters for the portfolio are a lead time of 2.5 to 3 months and minimum order quantities of 0.3 million tablets, 1 million capsules and 0.6 million gummies. Softgel and Chewable Burstlet minimums are not published in the same way and should be confirmed per project rather than inferred from the tablet or capsule figure.

Scale is the other side of the same question. Monthly capacity is reported at approximately 4.33 billion tablets, 500 million hard capsules and 375 million gummies, which is the number to compare against a forecast rather than against a first order. Quality control is stated as 100% test, and all products are manufactured in a GMP-grade clean area to meet international standards — both are specification-relevant commitments that should appear as acceptance language, not as background.

• Unit weight band — the numeric range the batch must fall inside, expressed as total weight per unit.
• Count tolerance — the permitted deviation from the declared count per bottle, per form.
• Shape conformity — approval of the specific mould or tooling before production, referenced by name.
• Pack integrity — seal and closure performance for the chosen pack: HDPE bottle with CRC cap, or aluminum blister where specified.
• Shelf-life commitment — the exact option selected (24 or 36 months; 12, 18 or 24 months for gummies) and the storage statement that will appear on the label.
• Documentation set — the records released with the batch, aligned to the CGMP expectation that product is packaged and labeled as specified in the master manufacturing record.
• Change control — who approves a later change to shell material, mould, pack or shelf-life claim, and how that change is documented.

Dosage form specifications are executed in GMP-grade clean areas; all products are manufactured to meet international standards, with 100% test as the stated quality control position.

FAQ

Conclusion

A dosage form specification is short, numeric and easy to read once the fields are known. For tablets it is a shape family and a 200–2,900 mg window. For hard capsules it is a size code, a 350–1,200 mg total weight that includes the shell, and a gelatin or vegetarian decision. For softgels it is five shapes at 250–1,200 mg in bottles of 60–450. For gummies it is one of 18 moulds at 2–7 g with a 12, 18 or 24-month shelf life. For Chewable Burstlets it is three shapes at 250–1,200 mg. Packaging is HDPE bottle, aluminum blister and CRC cap across four of the five forms, and HDPE bottle with CRC cap for gummies; storage is below 25°C throughout.

The buyers who get comparable quotations and clean audits are the ones who write those six fields down — shape, total weight, shell or base, count, pack, shelf life and storage — and then attach acceptance criteria to each. Everything else in the negotiation, from MOQ to lead time to price, is downstream of that one page.