Laboratory Protocols 8 min read Updated 2026-10-04

Bacteriostatic Water for HCG: What the Novarel and Pregnyl Labels Say

Most pages on this topic are mixing charts. This one goes to the FDA labels: what each HCG product is packaged with, the exact in-use period each label allows, what changes if sterile water is used instead, and how the 2020 biologics transition affected compounded HCG.

Written by PureBac Analytical Sciences Laboratory. Sourced from 11 primary references including the FDA-approved product label, USP monographs and general chapters, CDC injection-safety guidance, and peer-reviewed literature indexed in PubMed. How we write and check guides.

Two unlabeled glass vials with grey caps standing in a refrigerator door shelf, one holding white freeze-dried powder and the other holding clear liquid
IllustrationFDA-approved urinary HCG kits pair a powder vial with a matching diluent vial. The label's refrigerated clock starts when the two are mixed.

Key Technical Takeaways

  • HCG (chorionic gonadotropin) is a prescription drug. The FDA-approved urinary products come as a powder packaged with their own benzyl alcohol-preserved diluent.
  • Novarel is supplied with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol). Its label says to refrigerate the mixed vial and use it within 30 days.
  • Pregnyl's solvent is not plain bacteriostatic water: it is Water for Injection with 0.56% sodium chloride and 0.9% benzyl alcohol. Its label allows 60 days refrigerated and says not to freeze.
  • Ovidrel is recombinant HCG in a prefilled syringe. There is nothing to mix.
  • Since March 23, 2020, HCG has been regulated as a biological product, which removed it from the compounding exemptions in sections 503A and 503B.

1. The Short Answer

FDA-approved HCG (human chorionic gonadotropin) powders come packaged with their own benzyl alcohol-preserved diluent, so the question of which bacteriostatic water for HCG is answered inside the box. Novarel ships with Bacteriostatic Water for Injection, USP, and its label allows 30 days refrigerated after mixing.1 Pregnyl ships with a benzyl alcohol-preserved saline solvent and allows 60 days.2

HCG is a prescription drug. This page reports what the FDA labels say about diluents and storage. It does not cover dosing, and it is not a substitute for the label or the prescriber.

2. Bacteriostatic Water for HCG: What Four FDA Labels Specify

The pages that rank for this search are mostly mixing charts built around a generic “add bac water” step. None of the ones we checked in September 2026 compared the approved products' own labels, so this section does. We read the FDA prescribing information for three urinary-derived HCG products and one recombinant product and recorded, for each, the supplied diluent, the storage before mixing and the in-use period after mixing. The differences are small on paper and matter in practice.

ProductFormSupplied diluentStore before mixingAfter mixing, per label
Novarel 5,000 or 10,000 USP units1Powder vial + diluent vialBacteriostatic Water for Injection, USP, 0.9% benzyl alcohol20 to 25°C (68 to 77°F)Refrigerate 2 to 8°C, use within 30 days
Pregnyl 10,000 USP units2Multiple-dose powder vial + 10 mL solvent vialWater for Injection with 0.56% sodium chloride and 0.9% benzyl alcohol15 to 30°C (59 to 86°F)Refrigerate 2 to 8°C, discard after 60 days; do not freeze
Chorionic Gonadotropin for Injection, USP 10,000 USP units3Multiple-dose powder vial + diluentBacteriostatic Water for Injection20 to 25°C (68 to 77°F)Refrigerate 2 to 8°C, discard after 60 days
Ovidrel (choriogonadotropin alfa)4Prefilled syringe, 250 mcg in 0.5 mLNone, ready to injectSee labelNot applicable

Novarel and Pregnyl are labeled for intramuscular use; Ovidrel is labeled for subcutaneous use. Check the current label for your product; labels are revised.

3. Three Details the Mixing Charts Get Wrong

Pregnyl's solvent is preserved saline, not plain bacteriostatic water

Most guides say HCG is “mixed with bac water.” For Pregnyl that is not quite true. Its 10 mL solvent vial contains Water for Injection with 0.56% sodium chloride and 0.9% benzyl alcohol, and it carries its own “not for use in newborns” warning.2 The preservative is the same as standard Bacteriostatic Water for Injection (0.9% benzyl alcohol),5 but the solvent also contains salt. The label does not describe the two as interchangeable.

What is in each HCG diluent vial
Novarel and the generic Chorionic Gonadotropin for Injection, USP use bacteriostatic water with 0.9% benzyl alcohol, Pregnyl's solvent adds 0.56% sodium chloride to the same preservative, and Sterile Water for Injection contains no preservative and is not supplied with any of them. Sources: FDA labels for Novarel1, Pregnyl2 and Chorionic Gonadotropin for Injection, USP3.

The in-use period is 30 or 60 days, not 28

The familiar 28-day rule is the default for a punctured multiple-dose vial when the manufacturer gives no other date.6 HCG labels give their own date. Novarel says to refrigerate the reconstituted product and use it within 30 days.1 Pregnyl and the generic Chorionic Gonadotropin for Injection, USP allow 60 days refrigerated.23 The manufacturer's number takes precedence over the general rule; more on how the two interact in our 28-day puncture rule guide.

HCG after mixing: the label clock vs the 28-day default
Once mixed and refrigerated, Novarel is labeled for 30 days and Pregnyl and generic Chorionic Gonadotropin for Injection, USP for 60 days, compared with the USP 797 default of 28 days for an opened multiple-dose vial; a vial mixed with sterile water has no label-backed period. Sources: Novarel1, Pregnyl2 and Chorionic Gonadotropin for Injection, USP3 labels; USP <797>6.

The volume is set by the label

The generic Chorionic Gonadotropin for Injection, USP label describes transferring 10 mL of diluent into the 10,000-unit vial and agitating gently until the powder dissolves.3 That gives a concentration of 1,000 USP units per mL. Pregnyl's kit pairs its 10,000-unit vial with a 10 mL solvent vial.2 Novarel's label is the one that lists two volumes: 1 mL when the whole vial is given at once, or 10 mL for multiple-dose use with the vial refrigerated between doses.1 Charts that suggest some other volume change the concentration the label and the prescription are written around. How much of that solution any person uses is a prescribing decision, not something a chart can supply.

Why the labels are conditional. Novarel's storage statement reads as a condition: when reconstituted with Bacteriostatic Water for Injection preserved with 0.9% benzyl alcohol, refrigerate and use within 30 days.1 The 30 days belongs to that combination. Change the diluent and the label no longer tells you how long the vial is good for.

4. HCG and Sterile Water

“HCG sterile water” is a common search, usually from people whose kit is missing its diluent or who have heard sterile water is “purer.” Both are reasonable questions, and the labels answer them:

  • None of the three urinary HCG labels above supply sterile water. Each supplies a benzyl alcohol-preserved diluent.123
  • Sterile Water for Injection has no preservative. It is intended for single use. Pregnyl and the generic product are sold as multiple-dose vials, and a multiple-dose vial is drawn from repeatedly over weeks. Without a preservative, nothing limits growth of bacteria carried in on each needle entry.
  • The newborn warning is not relevant to most HCG patients, but it is the reason preservative-free diluents exist. Benzyl alcohol in flush solutions and diluents was linked to neonatal deaths reported in 1982.7

If a diluent vial is lost or broken, the pharmacy that dispensed the HCG can replace it or advise on an equivalent. That is a better answer than improvising. For a fuller comparison of the two waters, see bacteriostatic water vs sterile water.

5. Mixing HCG and Bacteriostatic Water: What the Label Covers

The generic label's instructions are short: withdraw air from the powder vial and inject it into the diluent vial, withdraw 10 mL of diluent, add it to the powder vial, and agitate gently until the solution is complete.3 Beyond that, standard aseptic handling applies: a new sterile needle and syringe for every entry, and wiping the stopper with alcohol before each puncture. Our reconstitution technique guide covers the general method; for a dispensed product, the instructions in the carton come first.

After mixing:

  • Refrigerate at 2 to 8°C (36 to 46°F).
  • Write the mixing date on the vial and count forward 30 or 60 days, depending on the product.
  • Do not freeze. Pregnyl's label says so explicitly.2
  • Discard at the label's limit even if solution remains.

6. Ovidrel: The Product With Nothing to Mix

Ovidrel is choriogonadotropin alfa, a recombinant HCG. It is supplied as a sterile liquid in a prefilled syringe that delivers 250 mcg in 0.5 mL for subcutaneous injection.4 There is no diluent to choose. Recombinant and urinary HCG are dosed on different scales (micrograms versus USP units), so one is not a direct swap for the other without a prescriber's decision.

7. Compounded HCG After March 2020

HCG was historically approved as a drug under the Federal Food, Drug, and Cosmetic Act. Under the Biologics Price Competition and Innovation Act, approved applications for certain biological products were deemed biologics licenses on March 23, 2020. FDA's notice to compounders explains that products that made this transition are no longer eligible for the compounding exemptions in sections 503A and 503B.8 FDA correspondence for Pregnyl confirms that its application was converted to a biologics license on that date.9

The practical effect is that the compounding exemptions no longer cover HCG, which makes the FDA-licensed products in the table above, each with its own supplied diluent, the reference point for how HCG is mixed and stored.

FDA on HCG sold for weight loss

FDA is also clear about one use: there are no FDA-approved HCG products for weight loss, and HCG products sold over the counter as “homeopathic” are illegally marketed.10 The agency's consumer update goes further: HCG “is not approved for use without a prescription for any purpose,” and the weight-loss products it warns about are sold as drops, pellets and sprays online, at weight loss clinics and in some retail stores.11 The FDA official quoted in that update put the evidence this way:

“These products are marketed with incredible claims, and people think that if they're losing weight, HCG must be working ... But the data simply do not support this; any loss is from severe calorie restriction. Not from the HCG.”

Carolyn BeckerDirector, Office of Unapproved Drugs and Labeling Compliance, FDA Center for Drug Evaluation and Research (as identified by FDA)FDA Consumer Update

FDA also reports receiving serious adverse event reports tied to HCG injections used for weight loss, including pulmonary embolism, cardiac arrest and death.10 For a diluent guide, the practical point is simple: the labels in section 2 describe a prescription product mixed and stored under a prescriber's direction, and nothing else.

8. Before You Mix: What to Check on the Carton

HCG kits are simple, but a few details are worth confirming before the first puncture, because they decide the storage clock that follows:

  • Both vials are present and match. The powder vial and the diluent vial come as a pair. The diluent in a Pregnyl kit is not the same liquid as the diluent in a Novarel kit.
  • The powder was stored as labeled. Room temperature before mixing for the three urinary products above, within the ranges in the table.
  • The expiration dates are in range. Check both vials. The mixed product's 30 or 60 days does not extend past the date printed on the kit.
  • The flip caps are intact. A missing cap on a new vial is a reason to return it, not to mix it.
  • You know which in-use period applies. Write the mixing date and the discard date on the vial label as soon as it is mixed.

Storage rules for the diluent itself, before and after it is opened, are covered in our bacteriostatic water storage guide.

9. Where Generic Bacteriostatic Water Fits

Standard Bacteriostatic Water for Injection, USP matches the diluent described on the Novarel label: sterile water with 0.9% benzyl alcohol. It is itself an Rx-only product, approved only to dilute drugs according to the drug manufacturer's instructions.5 For a prescribed HCG product, those instructions point to the diluent in the kit. What the full name on a vial certifies is explained in our USP label guide.

10. Summary

  • HCG is prescription-only; the product label and prescriber govern the diluent and use.
  • Novarel: Bacteriostatic Water for Injection, 0.9% benzyl alcohol; 30 days refrigerated after mixing.
  • Pregnyl: Water for Injection with 0.56% sodium chloride and 0.9% benzyl alcohol; 60 days refrigerated; do not freeze.
  • Generic Chorionic Gonadotropin for Injection, USP: bacteriostatic water, 10 mL; 60 days refrigerated.
  • Ovidrel is a ready-to-use recombinant syringe.
  • Sterile water removes the preservative the labels' storage periods depend on.
  • FDA: HCG is not approved without a prescription for any purpose, and no HCG product is approved for weight loss.

Frequently Asked Questions

What do you mix HCG with?

The diluent packaged with it. Novarel comes with Bacteriostatic Water for Injection, USP containing 0.9% benzyl alcohol. Pregnyl comes with a solvent of Water for Injection with 0.56% sodium chloride and 0.9% benzyl alcohol. Ovidrel is a prefilled liquid that needs no mixing. HCG is prescription-only, so follow the product label and the prescriber.

Can you use sterile water for HCG instead of bacteriostatic water?

The FDA labels for Novarel, Pregnyl and generic chorionic gonadotropin supply a benzyl alcohol-preserved diluent, and their 30 or 60 day refrigerated in-use periods assume it. Sterile water has no preservative, so a vial mixed with it has no label-backed storage time beyond a single use. Only a prescriber or pharmacist should direct a different diluent.

How long is HCG good for after mixing with bacteriostatic water?

It depends on the product label. Novarel's label says to refrigerate the reconstituted vial at 2 to 8 C and use it within 30 days. Pregnyl's label and the generic Chorionic Gonadotropin for Injection, USP label allow 60 days refrigerated before the vial is discarded. Pregnyl's label also says not to freeze it.

Does HCG need to be refrigerated before mixing?

Not for the urinary HCG powders we checked. Novarel and generic Chorionic Gonadotropin for Injection, USP are stored at 20 to 25 C (68 to 77 F) before reconstitution, and Pregnyl at 15 to 30 C (59 to 86 F). Refrigeration starts after the powder is mixed.

Can pharmacies still compound HCG?

On March 23, 2020, approved HCG applications were deemed biologics licenses. FDA's notice to compounders says products that made this transition are no longer eligible for the compounding exemptions in sections 503A and 503B of the FD&C Act.

References & Primary Sources

Every technical claim on this page is sourced to a pharmacopeial monograph, a federal regulatory body, or peer-reviewed literature. Links open the primary source directly.

  1. Regulatory / pharmacopeialNOVAREL (chorionic gonadotropin) for injection: Prescribing InformationDailyMed, U.S. National Library of Medicine (NIH) · FDA-approved label; supplied with 10 mL Bacteriostatic Water for Injection diluent
  2. Regulatory / pharmacopeialPregnyl (chorionic gonadotropin) for injection: prescribing informationU.S. Food and Drug Administration (Drugs@FDA) · Application 017692, label approved 2023
  3. Regulatory / pharmacopeialChorionic Gonadotropin for Injection, USP, 10,000 USP units: prescribing informationDailyMed, U.S. National Library of Medicine (NIH) · FDA-approved product label, SPL set ID f93b2baa
  4. Regulatory / pharmacopeialOVIDREL (choriogonadotropin alfa injection) PreFilled Syringe: prescribing information (EMD Serono)DailyMed, U.S. National Library of Medicine (NIH) · FDA-approved product label, SPL set ID a683e58a
  5. Regulatory / pharmacopeialBacteriostatic Water for Injection, USP: FDA prescribing information (Hospira, Inc.)DailyMed, U.S. National Library of Medicine (NIH) · FDA-approved product label, SPL set ID 87d6e9dc
  6. Regulatory / pharmacopeialGeneral Chapter ⟨797⟩ Pharmaceutical Compounding: Sterile PreparationsUnited States Pharmacopeia · USP-NF general chapter · full text requires a USP subscription; the public page shows a preview
  7. Public health authorityNeonatal Deaths Associated With Use Of Benzyl Alcohol, United StatesCenters for Disease Control and Prevention · Morbidity and Mortality Weekly Report, 1982
  8. Regulatory / pharmacopeialNotice to Compounders: Changes that affect compounding as of March 23, 2020U.S. Food and Drug Administration · Human Drug Compounding
  9. Regulatory / pharmacopeialPregnyl (chorionic gonadotropin) supplement approval letterU.S. Food and Drug Administration (Drugs@FDA) · Application 017692, supplements S-028, S-036, S-043, 2023
  10. Regulatory / pharmacopeialQuestions and Answers on HCG Products for Weight LossU.S. Food and Drug Administration · Medication Health Fraud
  11. Regulatory / pharmacopeialAvoid Dangerous HCG Diet ProductsU.S. Food and Drug Administration · Consumer Update; content current as of July 13, 2020
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